Drug Books

Drug - Approvals

Cut Drug Approval Time with a 505(b)(2)
Yes, you can speed up your company's drug approval time - by using the 505(b)(2) process. Is a Section 505(b)(2) the right way for your company to go? This valuable management report, Cut Drug Approval Time with a 505(b)(2) gives all the details on how your company could get a break and only have to provide a limited number of studies (or smaller ones), cutting your costs and shortening your development time.

Expediting the FDA Generic Drug Approval Process
The FDA continues to struggle to catch up on ANDA approvals. Average time to approve: Three years. Three long years. While It's not well known, there are ways you can speed the approval process. Inside the pages of Expediting the FDA Generic Drug Approval Process you'll discover the three strategies for faster ANDA approvals and how to thread your way through the FDA maze.

Special Protocol Assessment: Winning FDA Support for Trial Design
A new FDA draft guidance gives drug sponsors detailed advice on how to take advantage of the opportunity to have agency staff review your protocol before you begin your trial. This management report explains what kinds of trials are eligible, how the process works and what to do if the FDA doesnt agree with your plans.

Drug - Audits

20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports
What are your requirements for postmarket surveillance reporting in international markets? This Brief outlines the new ICH guidance adopted by the FDA in July 2016 providing detailed information on what each of the 20 modules should contain and how to conduct benefit-risk analysis.

Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance
There's no doubt: complying with the detailed labeling requirements of every country in which you sell your products is a daunting task. But ... there is one established way to minimize your company's labeling errors and successfully sail through inspections. Setting up your own labeling self-audit programs. And this management report from FDAnews shows you how to do just that.

Drug - Biosimilars

Strategies for Biosimilars Approval: A Map to 351(k) Success
Want to know how Sandoz was the FDA's first biosimilar approval? Learn how Sandoz navigated the agency's approval process. FDAnews has a new management report that will give you candid "what to do - and how to do it" advice. Discover how to minimize the amount of time it takes to get your biosimilars approved - so you can speed your product to market and maximize your revenue generating potential.

Drug - Company Core Data Sheets

Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014
Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today. The CCDS is the prime reference document for every one of your drugs or biologics - the central document regulators and resellers rely on to label and manage the drug's use. what's the best way to correctly handle these essential documents? Make sure you're up to speed with the authoritative report from FDAnews.

Drug - Data Integrity

Avoiding Data Integrity Breaches: A Guide for Drugmakers
With this report, you'll get concrete, proven tools and techniques to help you identify existing - and potential - data integrity problems. It will show you how to design and deploy your own remediation strategy, using a risk-based approach to help you prioritize your efforts. Step by step, you'll see how to create a corporate culture that's conducive to data integrity protection, develop a risk-based oversight and prevention system, and recruit, train and retain employees who will responsibly work to ensure the integrity of your company's data.

Data Integrity in the EU: Requirements for Quality Management Systems
You may know all the principles of data integrity as the FDA sees them. But, do the same principles apply in Europe? The EMA, MHRA and WHO all have data integrity guidelines. And, their regulations dont always agree. Eliminate the guesswork with the report that details the ins and outs of all three documents and explains how the FDA regulations fit in.

Drug - EU

Annex 11: How to Comply with the EU's New Requirements for Computer Systems
Just when you think you?ve got the FDA's Part 11 validation rules under control, the EU has issued its new Annex 11 requirements. Here's how to retool systems and rethink risk management, fast. This management report from FDAnews provides drugmakers and suppliers with a thorough overview of the EU's risk management approach. With this concise source, you'll learn how to work with the new Annex 11 requirements for computer-related procedures.

Pharmacovigilance in the European Union: A Guide to New Directive
Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life. This report will help readers navigate the EU's complicated regulatory landscape and stay compliant.

Understanding EU Drug Safety Reporting
Are your pharmaceuticals still safe to sell in Europe? And how can you tell? These questions have never been timelier. The new European Pharmacovigilance Risk Assessment Committee (PRAC for short) gets closer to full operation each day. Next year, when it hits full stride, U.S. drug exporters will find themselves playing under all-new rules. It's time you got up to speed - and doing so has never been easier.

Drug - Generics

Achieving ANDA Success: Working with the FDA to Win First Cycle Approval
ANDA approval in the first review cycle is always the goal but seldom the reality. This report explains how to meet the challenges and avoid the pitfalls in pursuing first-cycle ANDA approval.

Drug - GMP

The New Excipient GMP Standard: A Guide for Drugmakers
The final NSF/IPEC/ANSI 363-2014 excipient GMP standard is the first American national standard for good manufacturing practices of pharmaceutical excipients ... and was created with significant FDA input. It is absolutely critical to every drug manufacturer's operation, helping you ensure that your quality controls will keep your product from being at risk - no matter where you are in the supply chain. And with a recommended deadline for compliance in the third quarter of 2015, time is of the essence for you to get up to speed on the new requirements. This new report from FDAnews takes drugmakers on a detailed introductory tour of the 363 standard, beginning with how it aligns with (and differs) from the IPEC-PQG guide of 2006 and continuing through many of the new standard's key requirements.

Drug - HCT/P

Managing HCT/Ps Under the FDA's New Guidelines
Two important FDA draft guidances released in late 2014 regarding human cells, tissues and cellular/tissue-based products (HCT/P) say that some companies not previously regulated by the FDA may now fall under the FDA's oversight. If you haven't been FDA-regulated, you're about to enter a complicated new world. Let FDAnews' expert editorial staff provide you with a thorough analysis of the FDA's proposed oversight of HCT/Ps, focusing on what the new draft guidelines mean for you.

Drug - Inspections

Pre-Approval Inspection: Four Steps to Success
This FDAnews Brief gives you a concise, point-by-point map to follow to pre-approval success, from developing an inspection SOP to making logistical decisions to handling investigators questions effectively, and surviving the data integrity audit.

Surviving an FDA Inspection
Under the FDA's new inspectorate reorganization, the agency is using specialized teams of highly trained investigators. This is making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips.

The FDA's New Inspection Practices: A Guide for Drugmakers
Your next inspection will not be like your last one! This management report explains the FDAs plans for upgrading its inspectorate and provides the key resources you will need to prepare for your next inspection.

Drug - Japan

Japan's New Fast Track Pathway for Drugmakers
Japan is encouraging pharmaceutical companies to get new products approved first there, or at the very least, parallel to the US and EU, with It's new "Sakigake" expedited pathway. Started in April 2015, the pathway is similar to the FDA's breakthrough designation - potentially cutting approval time in half. If you're going to bring your drugs to this massive market, you need this information to prepare for its unique challenges.

Drug - Latin America

Pharma Strategies in Latin America: Keys to Success
This report covers all you need to know about entering the Latin American market, from research and clinical trials to postmarketing surveillance.

Drug - Manufacturing

FDA Pharma Manufacturing Essentials: Executive Briefings on 15 of Your Biggest Challenges
This book brings together tested and practical advice that tackles the most pressing issues a pharma executive faces ... all in one, high-level and comprehensive resource. You can use FDA Pharma Manufacturing Essentials like a yearbook - assessing how the regulatory events will affect every aspect of your business in the coming year. It's the desktop reference you'll use not only today but for years to come.

Drug - New Drug Application

Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements
This book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed make it to the marketplace.

Drug - Off-Label

Off-Label Drug Promotion after Amarin: Interpreting the FDA's Stance
The federal court ruling in Amarin allows drugmakers to make truthful statements about Vascepa. But what does that really mean? Find out in this management report.

Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?
The FDA has historically taken a firm, restrictive stance on drugmakers communications about off-label uses of their products. Now, with the FDA settlement agreement with Amarin, other drugmakers are wondering what this means for them. Is this an Amarin only issue or does it have broader implications

Drug - Quality

Mastering Batch Record Review
Batch record review is a necessary but thankless task. Many drug manufacturers fob it off on the least trained, most junior QA/review staffers ... but that's a mistake. Failure to comply with FDA batch record review processes is among the Top Ten most frequent deficiencies cited during agency inspections of drug and biologics manufacturers. Why risk a Form 483 or warning letter when It's so easy to do batch record reviews right?

Drug - Regulations

Drugmakers Guide to the 21st Century Cures Act: Changing the Face of Pharmaceutical and Biologics Regulation
The newly passed 21st Century Cares Act doesnt just force an adjustment of the FDAs policies. It calls for a sea of change in the waters you have learned to navigate so well. This report tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes.

FDAnews Guide to International Pharma Regulation 2015
Learn about the regulatory developments affecting drug production in more than 22 nations around the world. Our editorial staff has compiled more than 150 reports highlighting changes from the past year, cover key issues such as emerging changes in inspection practices, changes to quality manufacturing requirements, new biosimilars legislation and regulation, changing product registration requirements, evolving patent laws and more.

Generic Drug Development: A Guide to FDA Regulation
A pathway has opened to speed generics to market. This report contains all of the FDAs generics-related guidances, plus internal agency policies on reviewing applications, instructions for challenging patents and even lists of branded drugs with expired patents and no generic competition.

Drug - Response Letter

FDA Complete Response Letter Analysis: How 51 Companies Turned Failure to Success
A complete response letter (CRL) from the FDA will delay a product's entry to the market by an average of two years; six months for those under priority review. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can with FDAnews' latest publication.

Drug - Supplements

Dietary Supplement Inspections: A Comprehensive Guide to FDA Focus Areas and Expectations
Dietary supplement makers: The party's over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA's focus. In addition to warning letters, the agency is filing lawsuits and even seizing product. what's a supplement manufacturer to do? Dietary Supplement Inspections spells out how to cope with this new era of enforcement, with tips and how to-strategies to prepare for inspections and avoid GMP violations cited in 483s and warning letters.

Drug - Supply Chain

Global Supply Chain Management for Drugmakers
This management report looks at the status of developing regulations in the US and around the world — e.g., the EU, Turkey, India, China, Brazil, Argentina and Korea — and explains what drugmakers must do to meet upcoming compliance deadlines. Readers will learn how to meet the challenges of implementing a global supply chain security system and how to balance risks with the opportunities a well-crafted system can present.

Managing the Drug Supply Chain: Best Practices
This all-new management report from FDAnews helps you keep tabs on suppliers from Boston to Bangladesh. Supplier qualification and quality agreements. Timely and effective audits. These are but two of the dozens of key topics covered in Managing the Drug Supply Chain: Best Practices. You'll discover procedures you can implement now that ensure the strength of each supply-chain link for years to come.

Drug - Technical

A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q 10 Compliance
The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A pity, then, that most drugmakers didn't use a lifecycle approach when ICH Q10 made its bow ... and didn't have a clue as to how to begin. Many still Don't. This all-new management report helps you bring your drug manufacturing quality systems into compliance.

Computer System Validation in the EU
If you manufacture drugs for sale in the EU, beware. Your own computers may be setting a trap for you. Computer validation is the issue. Just when you think you've got the FDA's requirements figured out, the EU issues its own. Do you know how they differ? Will you be able to satisfy tough audit trail and personnel requirements? And what about your suppliers' systems, procedures and networks: are they all compliant? Make no mistake: EU inspectors are watching you. Best to learn the rules before making a false step.

Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Did a truck driver just ruin a drug shipment? Not only do you need to protect your drugs from tampering ... you must shield your drugs from the extremes of heat and cold during transit ... and store and dispense your products so they're as safe and effective as they were when they left the plant. That means companies like yours need to begin NOW to create a master plan that establishes how your distribution chain will protect the integrity of your products, from the very beginning of your supply chain all the way to the customer's doorstep. This report is the ultimate guide to preparing your company for compliance with Good Distribution Practice (GDP).

Documenting Process Validation: A Drugmaker's Guide
Few things in drugmaking are as challenging as process validation - nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that It's been done. FDA inspectors examiners are trained to be sticklers, and their mantra: "If it isn't written down, it didn't happen." With this management report you'll discover how to document process validation in a way that's sure to satisfy - and impress - regulators.

Drugmaker's Guide to Global Quality API Manufacturing
Published by the global GMP consulting firm Maas & Peither AG and distributed by FDAnews, Drugmakers' Guide to Global Quality API Manufacturing is the last word on current regulations, guidelines, and auditing standards for APIs. It features a walk-through of recent revisions to GMP-compliant manufacturing standards, testing, and proper movement of APIs within the EU, including vital documents and other essentials for registration. This section alone is worth the full purchase price.

Electronic Batch Recording and Batch Release for Drugmakers
Introducing and implementing an EBR system is complex. To succeed, a conversion requires systematic analysis, definition and a complete assessment of all regulatory requirements, process-based data and product-relevant information. This management report leads you step-by-step through key thought processes and issues you may confront in planning to move to an electronic batch recording system.

Electronic Document Management Systems for Drugmakers
Converting a paper-based documentation system into an electronic document management system (eDMS) is a win-win for drug manufacturers, the FDA and the EU. But difficulties lie in the complexity of converting from paper to electronic: the selection, design, implementation and validation of your plan. Electronic Document Management Systems for Drugmakers, a new management report from FDAnews, tackles all those difficulties - the key concepts, various issues and tricky interrelationships with other systems - that you must deal with during a conversion to a validated eDMS.

Environmental & Microbiological Monitoring at Drug Manufacturing Sites
This just-released report provides you with the essential in-depth knowledge you need to correctly monitor the hygienic status of your sterile drug sites and evaluate your cleaning and disinfecting measures. Step by step, you'll go through the 4 key monitoring processes ... risk analysis and defining contamination limits ... planning and conducting sampling ... evaluating your findings ... and making modifications. And you'll get a detailed look at monitoring and testing 3 critical areas: surfaces, personnel and air. The report also covers monitoring and testing utilities, cleansing agents and disinfectants.

GMP Inspection Preparation Checklist: A Tool for Internal Auditing and Training
Dont let your next inspection stress you out. This comprehensive checklist of questions investigators typically ask is the ultimate cheat sheet for your next inspection.

Managing Contract Manufacturers and Testing Labs
This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk you through an exhaustive, 45-topic analysis of managing contractors. Plus It's loaded with tools and samples that will make your contract manufacturing headaches disappear. The report addresses all the topics you'll need to consider when contracting.

Managing Contract Manufacturers and Testing Labs: 2016 Edition
Creating a contract manufacturer management system is a huge undertaking. Fortunately, the experts behind the internationally recognized GMP Manual have laid out all the details in this comprehensive, step-by-step guide.

Managing Process Validation: A Drugmakers Guide
Written by international pharma industry veteran and GMP specialist Dr. Christine Oechslein, this report gives you the information you need to craft a solid validation program that will satisfy US and EU regulators.

Pharma Change Control: Strategies for Successful Company-Wide Implementation
Drugmaking processes change constantly. New companies enter the supply chain, old ones drop off. New production machinery and software supplant old stuff. Things get complicated and before you know it, your files are filled with new specifications and revised SOPs. But the FDA likes things simple, clear cut and well tracked. That leaves you a lot of questions. Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes.

Preparing for the EU GMP Inspection
The FDA's GMPs and the EU's GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two. This new handbook from FDAnews tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections. FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you'll refer to whenever the EU inspectors come to call

Quality Risk Management for Pharmaceuticals
Drugmakers must have an effective quality system. However, a basic quality system that just covers the GMP requirements is no longer good enough. This management report will tell how QRM can be applied both proactively and reactively and explore the potential application of QRM during the different phases of the product lifecycle.

Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors
What questions do you need to ask to make sure you select the best suppliers and contractors? This report includes two checklists the API and Excipient Supplier Checklist and the Contract Manufacturing and Analysis Checklist that will guide you through the process so that you dont have to worry about missing any points or asking the wrong questions.

The Drug Manufacturer's Guide to Site Master Files
Beginning in January of this year, all European inspectors began asking for a site master file that complies with the 2011 PIC/S revisions to GMPs. If you Don't have an updated site master file - or a site master file at all - you're out of compliance with dozens of new or changed requirements. This management report from FDAnews will help you perform a comprehensive gap analysis that assures your Site Master File matches your company's activities.

Drug - Validation

Developing a Compliant Drug Validation Plan
This management report will tell you how to develop and implement a drug validation plan that will satisfy FDA and international regulators. It focuses on using ASTM E2500 and ICH Q9 to create risk-based assessments that increase compliance, minimize the spiraling costs of validation and reduce project delivery time. This report also provides a step-by-step approach to the planning, execution and reporting of computer system validation activities.

Drugmaker's Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and FDA Compliance
This management report explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations.

Device Books

Device - 483's

Managing Device Purchasing Controls
Form 483s issued to devicemakers in 2014 for purchasing control violations were up 17 percent over 2013. While nearly every other section of the QSR showed decreases, purchasing controls were mentioned in 129 Form 483s - up from 110 in 2013. If you're concerned - and you should be - order a brand-new management report from FDAnews, Managing Device Purchasing Controls, that will make a huge difference to you and your company. This report is written to help devicemakers like you avoid problems by outlining 5 simple steps tied closely to the precise regulatory language governing purchasing controls.

Device - 510(k)

Achieve 510(k) Notification Success for Device Software
How do you know if your software is a medical device in the eyes of the FDA and requires a 510(k) premarket notification? And if your software is a regulated device, how do you know if the software requires a complete 510(k) or if it is eligible special 510(k) or abbreviated 510(k), both of which have much easier requirements to satisfy. This report will walk you expertly through the steps you need to take to move your notification forward as quickly as possible, and without any extra work on your part.

Device - CAPA

Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers
Ten of the industrys top medical device experts, who have together managed thousands of root cause investigations and successfully opened and closed more CAPAs than they can remember, share everything from the nuts and bolts of CAPA management to the most innovative best practices.

Device - CDRH

CDRH in Transition: Navigating the New Culture of Quality
Under CDRHs new inspection system, your team of investigators will include at least one specialist in your product area, making it harder to hide your faults. This report outlines the Culture of Quality programs goals and explains how they will change the way devicemakers experience inspections.

CDRH in Transition: Preparing for a New Enforcement System
The looming realignment of CDRHs programs and retooling of inspection procedures have raised many questions among devicemakers trying to prepare for future inspections. CDRH in Transition: Preparing for a New Enforcement System outlines how and when CDRH plans to update its programs in the coming years and how devicemakers should respond.

Device - Complaints

Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends
Its certain that your complaint management system will come under intense scrutiny in your next GMP inspection. This report teaches the principles of effective systems as well as how to analyze trends in complaint files to spot opportunities for product and program improvement.

Medical Device Complaint Management - 2016 Edition
This updated for 2016 management report is written especially to help you avoid warning letters and other FDA sanctions — by spelling out in plain English the do's and don'ts of effective device complaint management. It's certain that the FDA's inspectors will examine your complaint management reporting systems on their next visit. So, there's no time like the present to begin creating systems that integrate data collection, complaint evaluation and risk assessment, as well as processes that determine how complaints are categorized and whether they are valid.

Medical Device Complaint Management: A Guide for Compliance - 2010 Edition
It's certain that the FDA's inspectors will examine your complaint management reporting systems on their next visit. So, there's no time like the present to begin creating systems that integrate data collection, complaint evaluation and risk assessment, as well as processes that determine how complaints are categorized and whether they are valid. This management report is written especially to help you avoid warning letters and other FDA sanctions - by spelling out in plain English the do's and don'ts of effective device complaint management.

Device - Computers/Technology

Cybersecurity, Privacy and Security Guidance for Medical Device Manufacturers
With electronic medical devices capable of logging and storing more and more data on device use and patient health, cybersecurity risks from medical devices are growing. Even the FBI recently warned the industry that this will create a rich environment for cybercriminals to exploit. What can you do now to prepare? This management report from FDAnews will give you what you need to deal with cybersecurity risks and HIPAA/HITECH compliance.

Device Software Safety Risks
Compliance with IEC 62304 is required for all electromedical devices where basic safety or essential performance depends on software or firmware. However, many devicemakers - especially small to mid-size companies - are unaware that their devices must meet this standard. Failure to comply can mean the FDA's disapproval of the product - for both new and revised versions. This new report provides you with best practices that will help you understand and successfully comply with IEC 62304.

Hack-Proofing Medical Devices: Ensuring Product Safety Through Cybersecurity
How does the FDA expect you to fight cyber incursions? This management report will show you how to get and keep control of your devices networked operations.

Medical Device Mobile Apps
With its guidance on apps, the FDA declared health-related apps fall under its jurisdiction - just like any software that is intended to assist in diagnosing or treating an illness. That means developers of health-related mobile apps for use on tablets and smartphones need to assess their apps to determine if FDA views them as a medical device. And, if it does, what the regulatory obligations are. With this management report your mHealth project will stay on schedule and in compliance.

Mobile Medical Apps: Keeping Up with the FDAs Evolving Requirements
Just because an app is running on an unregulated phone or tablet doesnt mean that the app itself isnt a medical device in the FDA's eyes. Where does the agency draw the line between unregulated products and those it must approve? This management report explains what the FDA means by enforcement discretion and how it considers an apps intended use in category assignment.

Device - Inspections

Medical Device Inspections Guide
Do you prepare your medical device facility for an FDA inspection the same way you did last year - or even six months ago? If you do, you could be in big trouble. The rules of the game have changed and the FDA is cracking down harder than ever ... the CDRH issued 142 warning letters in the past year alone. So, it's more important than ever to make certain you're fully informed of the latest rules and regulations the FDA has introduced. This recent edition has the answers to all your toughest questions.

Medical Device Inspections Guide 2016
Do you prepare your medical device facility for an FDA inspection the same way you did last year or even six months ago? If you do, you need to rethink that. FDA inspections are getting tougher every day. You need to be well-versed in the regulations you must follow and the procedures the agency will use to conduct your inspection. This brand-new edition is a one-stop source for all the regulations, guidances and policies that impact medical device inspections.

Use QSIT to Your Advantage in FDA Device Inspections
This management report offers you a one-two punch of value and knowledge, relying on the combined expertise of Tim Wells, the man who literally wrote the book on QSIT inspections, and Jodi Scott of the law firm Hogan Lovells, an expert in QSR, adverse event reporting and field action requirements. With this report you'll find out how the FDA determines your risk profile, and learn important red flags that can alert you that an inspector is sniffing around for a specific problem

Device - Internal Audits

Effective Internal Audits and Quality Control Units for Devicemakers
The management report will show you how a strong internal audit program and quality control unit (QCU) can ensure your compliance with FDA requirements. You'll start by learning step-by-step what it takes to create and implement an effective, independent internal audit program and quality control unit (QCU) and see how important internal audits can be for your organization as a proactive tool and not just a "reaction" to a requirement. You'll also come to understand the FDA's expectations of your QCU, how to set up your unit properly and in compliance, and how to fix any problems with an existing QCU.

Device - International

Using the MDSAP Model to Win International Device Approval
This management report explains what MDSAP auditors will focus on and teaches you how to build an internal audit program that will get your quality system in state-of-the-art shape for international inspections.

Device - ISO 11607

Using ISO 11607 to Develop Risk-Based Device Packaging
Using case studies and other frontline knowledge this report will show you how to leverage a risk-based packaging approach to prevent nasty audits and recalls ... without busting a hole in your compliance budget. With it, you'll get step-by-step guidance through the bewildering FDA packaging requirements, beginning with a discussion of how and why packaging is causing significant harm to devicemakers. You'll also learn why your packaging might be at risk - and what you must do to reduce field complaints, recalls or FDA enforcement actions.

Device - Manufacturing

Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance
In this management report, you'll explore the modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks and improve performance.

Device - Medical Device Reports

6 Steps to a Stress-Free eMDR Rollout
The deadline for submitting eMDRs - August 14 - has passed. There will be NO MORE paper Form 3500As, no more MedWatch reports. Are you prepared for this major change? The new report from FDAnews, 6 Steps to a Stress-Free eMDR Rollout, will tell you everything you must know to transform your paper MDRs into electronic versions - and maintain FDA compliance.

Device - Nonconforming Product

Managing Nonconforming Product: A Devicemakers Guide to Compliance
Handling nonconforming products is one of the device industry's biggest headaches. Complying with FDA rules in the Quality Systems Regulation and international standards in ISO 13485 requires an almost Holmesian ability to dig out information and make accurate deductions. This management report does the sleuthing and deducing for you.

Device - Off-Label

Navigating Off-Label Device Promotion: How Will FDA Settlements Impact Devicemakers?
The FDA has historically taken a firm, restrictive stance on communications about off-label uses of products. But the agencys position has become increasingly uncertain as the courts address the subject of freedom of commercial speech. Will the recent decisions in the Amarin and Pacira cases open the door for devicemakers to broaden their communications?

Device - Premarket Submission

Devicemakers Guide to FDA Premarket Submissions, Vol. I
Which pathway should you take in gaining FDA authorization for your new device? Premarket Application (PMA) 510(k) Premarket Notifcation De Novo classification? Volume I of Devicemakers Guide to FDA Premarket Submissions focuses on Premarket Approvals and Human Device Exemptions and includes all of the information and documents you need to navigate the FDAs marketing process.

Devicemakers Guide to FDA Premarket Submissions, Vol. II
Which pathway should you take in gaining FDA authorization for your new device? Premarket Application (PMA) 510(k) Premarket Notifcation De Novo classification? Volume II of Devicemakers Guide to FDA Premarket Submissions includes all of the information and documents you need to navigate the 510(k) clearance and De Novo classification processes.

Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort
What premarket pathway should you consider for your new product? The De Novo program? Early Feasibility/First-in-Human Studies? The Expedited Access Pathway? This report explains the criteria for each pathway, how to determine which one is right for your device and strategies for success.

Device - Quality Systems

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls
Devicemakers must establish strict design control procedures as part of their quality management system. This brief shows where design control and risk management requirements overlap so devicemakers can serve both with one integrated effort.

QSR-Compliant Purchasing Controls: A Five-Stage Plan
The FDAs Quality System Regulation is very clear: you must maintain control of your supplier networks. Follow this five-step plan explains what the regulation requires and how to make sure your system passes muster.

Three Phases of QSR-Compliant Equipment Control
The FDAs Quality Systems Regulation says you must maintain, inspect and make adjustments to your equipment. What the nine-paragraph rule doesnt say is how. This brief helps fill in the gaps.

Troubleshooting Your Quality System: A Guide to Five Devicemakers Quality Compliance Traps
Medical device manufacturers often dread the FDA inspector's arrival. But here's a shortcut to success you can master in an hour or so. There is a little-known secret: Five problem areas account for one-fourth of all Form 483 observations the FDA issues devicemakers in a given year. Master these and you've taken a giant step toward inspection success. And now, FDAnews has created a management report focusing on just those five areas.

Device - Recalls

Corrections, Removals and Recalls: A Guide for Devicemakers
You face a tangled web of rules, interpretations, issues and actions that make it difficult to know how to proceed when you need to make a change to one of your medical devices. The Corrections, Removals and Recalls brief defines all the key terms and parses the FDA regulations that govern corrections, removals and recalls.

Medical Device Recall or Product Enhancement?: Understanding the FDA's Part 806 Guidance
Based on the FDA's most recent recall guidance, devicemakers now have to wonder if their product enhancements are: an acceptable product enhancement; a recall; a product enhancement that's now considered a recall; or neither a product enhancement nor a recall. This new management report provides the keys to unlocking a balance between expectations and your current product enhancement activities

Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806
Under 21 CFR Part 7, you are requested to report corrections or removals to your FDA District Recall Coordinator promptly. But under 21 CFR Part 806, you are required to report within 10 business days after initiating such corrections or removals. Not only are devicemakers running afoul of the FDA on this point, they're likely to under-report field actions by misinterpreting Part 806. When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies?

Device - Regulations

Biological Risk Evaluation and Management for Medical Devices
This report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Dealing with China's Regulatory Authorities: Tips for Devicemakers
Chinas medical device regulatory system has long been a puzzle to outsiders. This brief lays out the whole regulatory map and helps you understand the hierarchical structure of Chinas regulatory agencies and how to operate within the system.

Device Accessories: Understanding and Implementing FDA's Guidance
The 21st Century Cures Act requires the FDA to classify accessories. This FDAnews Brief explains the guidance document and gives you the tools needed to determine and document whether any of your products are a device accessory.

Devicemakers Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation
The newly passed 21st Century Cares Act doesnt just force an adjustment of the FDAs policies. It calls for a sea of change in the waters you have learned to navigate so well. This report tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes.

FDAnews Guide to International Medical Device Regulation 2015
Stay abreast of regulatory changes from Argentina to the United Kingdom ... more than 22 countries in all. This one-stop authority provides you with quick, accurate answers to questions on: safety monitoring; application processes for new device approvals; emerging changes in inspection practices; changes in global requirements for quality manufacturing, reporting, product registration, clinical trials, and much more.

Guide to FDA and EU Medical Device Regulations: 2017 Edition - Part 1
In addition to the full text of the FDAs medical device regulations and guidances, the 2017 edition for the first time includes the EUs Medical Device Regulation and In Vitro Diagnostics Regulation.

Guide to FDA and EU Medical Device Regulations: 2017 Edition - Part 2
In addition to the full text of the FDAs medical device regulations and guidances, the 2017 edition for the first time includes the EUs Medical Device Regulation and In Vitro Diagnostics Regulation.

Guide to FDA Medical Device Regulations 2015
Whether you need to help your company convince the FDA to accept a predicate device in a simple 510(k) filing or you're responsible for implementing UDI across a family of high-risk implantable devices, there's one thing all regulatory professionals need. The most up-to-date, latest FDA regulations available

Guide to FDA Regulation of In Vitro Diagnostic (IVD) Devices
IVDs, LDTs, RUOs, IUOs, ASRs, and GPRs regulation of in vitro diagnostic devices is an alphabet soup of confusion. This report brings together all the disparate parts of IVD regulations and guidances and provides an expert interpretation of requirements.

ISO 13485:2016 - A Devicemakers Transition Guide
Our team of experts has spent hours parsing out every clause in the new version of the rules and compared them to ISO 13485:2003.This report features a clause-by-clause, line-by-line, 46-page comparison of the old and new versions of 13485 that shows you exactly what and where the new requirements are.

ISO 9001:2015 - What Devicemakers Need to Know
This report explains how the recent revision totally restructures the standard, and breaks it down section by section to point out new requirements devicemakers must follow to maintain their certification.

MD Regulation in the EU vs US: Recent Revisions and Key Differences
Despite years of harmonization talks, the EU and U.S. still follow very different marketing approval processes. When the EU's MDD went into effect in 2010, those differences became even more pronounced. Failing to know the differences could handicap your time to market and ability to operate efficiently; failing to comply with them could shut you out of EU markets completely. This management report will help you get your medical devices into both U.S. and EU markets - without risking noncompliance nightmares in either.

Navigating China's Medical Device Regulations
Todays Chinese medical device market is not the one you knew 10 years ago. This report brings you up to date, explaining how the Chinese system and culture work, what the regulatory changes are, how to react to new requirements and what may come in the future.

Regulatory Challenges of Device Acceptance
Will your acceptance activities pass an FDA inspection? For device warning letters in 2012, acceptance activities, 820.80, was the fourth most frequently cited QSR section. Don't be among the companies who will be cited this year. Don't risk legal fees, delays and lost time. Get this new FDAnews management report - Regulatory Challenges of Device Acceptance - and help your organization quickly acquire a full understanding of all the relevant FDA regulations.

Seven Steps to Successful Medical Device Reimbursement
Its an intricate dance between medical device regulation and reimbursement one you need to start with the right steps to gain maximum success. This report walks you through seven key steps to strategically blend reimbursement and FDA regulatory issues.

Understanding China's New Medical Device Regs
China completely revised its medical device regulations in 2014, and the changes are beginning to take effect now. These revised regs touch on many areas: research and development, approval, manufacturing, and distribution of medical devices. And they affect all devices - those already on the market as well as the ones still in development. If you want to sell your medical devices in China, understanding the new rules is absolutely essential. Gain mastery of these important regulatory changes with this management report.

Understanding Chinas New Medical Device Regulations, 2016 Edition
What do the three major developments in Chinas medical device regulations in the past six months mean for manufacturers doing business in China? This new edition of Understanding Chinas New Medical Device Regulations tells you all you need to know about new requirements for registering medical devices in China, the CFDAs increased enforcement powers, revised classification rules and more.

Understanding the New EU Medical Device Regulations
The EU has just made sweeping changes to its medical device regulations (MDR) replacing the three current guidance directives with two massive regulations binding manufacturers to a variety of new requirements. This management report directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the impact on the development, marketing and monitoring of your devices.

Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports
If you want to market your device in Europe, you need to provide clinical evidence that the product is safe and effective. But if your development phase didnt include clinical trials, how can you make that argument? This FDAnews Brief walks you through the process of developing and writing a CER with a 7-point model that ensures you cover all the bases and have the greatest chance of success.

Device - Supply Chain

Managing the Device Supply Chain: Best Practices
This all new management report from FDAnews will teach you how to implement best practices for managing your suppliers, whether your company is large or small. It is an up-to-the-minute guide for selecting the right suppliers ... drawing up contracts with controls that actually work ... audit policies that work ... compliance with Unique Device Identifier (UDI) rules ... and much more!

Process Validation: A Guide for Devicemakers
When must a process be validated? That is the first crucial question devicemakers must answer. But with no clear guidance from the CDRH, finding the answer can be difficult. This FDAnews Management report - provides you with the answers. This report will walk you through each point in the decision-making process, including how to determine if a product can be "fully verified," and how FDA inspectors define that term.

Device - Unique Device Identifiers

Unique Device Identifier (UDI) Rule Implementation and Compliance Guide
The next time you hear about UDIs, it may be from an FDA investigator. Will you be ready with an answer? The rush to compliance is in full swing. By Sept. 24, 2015, all implantable, life-saving or life-supporting devices must comply with the new UDI requirements. By 2018 all devicemakers must be in compliance. It's already clear that implementation and compliance with this new rule is a very big challenge.

Device - Verification and Validation

Choosing the Best Device Sample Size for Verification and Validation - 2014 Edition
If you're like many manufacturers, you understand the essence of the 21 CFR 820.30 requirement: you must run enough test samples of a product so its test results can be successfully applied to full-scale production runs. This management report from FDAnews will help you select the right statistical methods to determine exactly how many units of a product you should test to satisfy the FDA

Choosing the Best Device Sample Size for Verification and Validation - 2016 Edition
In this 2016 updated management report from FDAnews will help you select the right statistical methods to determine exactly how many units of a product you should test to satisfy the FDA. Like many manufacturers, you understand the essence of the 21 CFR 820.30 requirement: you must run enough test samples of a product so its test results can be successfully applied to full-scale production runs.

Device Documentation: A Guide to Managing Four Critical Production Files
Do you understand the four critical production files of device documentation? These four types of files create an intricate web of documentation critical to producing quality products and complying with FDA and international regulations. This brief is a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.

Implementing an 11-Step Plan for Device Software Validation and Verification
The FDA is cracking down on companies that don't carry out device software verification and validation, issuing an increasing number of 483s and warning letters to 1) manufacturers of medical devices with embedded software, and 2) manufacturers of software used as a device itself. With this new report, you'll find out exactly what FDA inspectors are being trained to look for in terms of device software verification and validation

Implementing an 11-Step Plan for Device Software Validation and Verification, 2016 Edition
The report will help you interpret and apply all the rules and standards you must follow and show you how to set up an 11-step plan for device software validation and verification. Plus, this updated edition contains a new chapter outlining the software validation requirements in ISO 13485:2016.

Implementing Risk-Based Verification and Validation
Switching to risk-based verification and validation is likely to save you money on projects, plus reduce liability and recalls. Itwhat'ss a good business idea. And what's more, the FDA is pushing you to do it. But like any basic change, there's a learning curve. Are you ready? This all-new management report from FDAnews is just the ticket for drug and device manufacturers ready to take the first step ... and seeking a helping hand. Your guide, consultant John E. Lincoln, has more than 30 years of experience assisting drug and device manufacturers to design new products, pilot them, set up production, validate and bring them to market.

Drug/Device Books

Drug/Device - Approvals

Tools for Faster Drug and Device Development: FDA's New Pathways to Innovation
This comprehensive collection of FDA guidances and policies on drug and device development tools features a preface by noted FDA law expert Jim O'Reilly laying out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it.

Drug/Device - CAPA

Effective 483 Responses: Focus on CAPA Violations
Dont you hate sitting down to write your companys response to a 483? Wouldnt you like to know what other companies wrote, especially for CAPAs? Well now you can, with Effective 483 Responses: Focus on CAPA Violations.

Managing Effective CAPA Systems
Nine of the industry's top experts, who have together managed thousands of root cause investigations and successfully opened and closed more CAPAs than they can remember, share everything from simple nuts and bolts to the most innovative best practices.

Root Cause Analysis for Drugs and Devices
This management report provides a step-by-step guide to conducting an effective root cause analysis, from recognizing problems that need to be investigated to documenting the investigation so regulators can see you are on top of the situation. The report also includes root cause analysis templates readers can customize for their own investigation.

Drug/Device - Change Control

Taming the Control Change Beast: Creating and Maintaining Effective Change Control Forms
Each company must maintain a state of control for any process used to manufacture regulated product. Showing the FDA that you do the same thing the same way every time keeps you on the agency's good side. Most companies rely on change control forms to track changes and describe current states of control. This management report is indispensable for anyone involved in producing or maintaining these crucial documents.

Drug/Device - Combination Products

Combination Products cGMP Compliance
The FDA says combination product manufacturers have two options for GMP compliance: satisfy all device and drug GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other. This report will guide manufacturers in developing a strategy that makes not only good compliance sense but also good business sense.

Drug or Device? How the 21st Century Cures Act Impacts Combination Products
This report takes a close look at the FDAs new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA.

The Essential Guide to Combination Products cGMPS
With the FDA's new cGMP rules kicking in, many drug, biologics and device manufacturers remain unclear about how to comply. The rules, made final in January, affect every combination product - not a single one is "grandfathered." They require you not only to review your manufacturing procedures - particularly when different constituent parts are made at separate facilities - but also to: Review and/or modify SOPs; Review and/or modify QC/QA systems; Institute new employee training programs and protocols; And make top-to-bottom reviews of dozens of internal processes. It's a tall order, and time is short. Fortunately, help is at hand.

Drug/Device - Complaints

6 Steps to Managing Drug and Device Customer Complaints
This report provides expert advice on how to train your staff to respond to product complaints quickly and easily, with little or no fallout. You'll learn lessons from a 30-year customer service veteran on how to ... monitor and protect your company's reputation while still being truthful and honest about a problem ... document and manage conversations whether on the phone, in writing or online ... protect and build brand loyalty ... reduce risk and liability to your company and its workers ... and remain in compliance with the FDA

Drug/Device - Data Integrity

Top Ten Data Integrity Traps: How to Find and Fix Problems
Virtually every area of your operations impacts the integrity of your data. If you want to lock down your systems to make sure data errors cant creep in, you need to identify the common and often critical gaps that can lead to serious data integrity problems.

Drug/Device - Equipment Qualification

Equipment Design and Qualification: A Guide for Drug and Device Manufacturers
This report authored by international GMP expert Thomas Peither and associates describes how to create and qualify a design plan that will meet your manufacturing goals and regulators expectations.

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers
This report authored by international GMP expert Thomas Peither and associates lays out the basics of building a four-phase qualification plan that satisfies US and EU requirements.

Drug/Device - HCT/P

Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers
The regenerative medicine industry is rapidly growing and, with major court decisions, new and significant FDA guidance, and government enforcement actions, the regulatory landscape is more complex than ever. With this management report, you will learn what uses of human cells and tissue are regulated and when the FDA requires an HCT/P to go through the marketing approval process.

Drug/Device - Human Error

Reduce Human Error in Drug and Device Manufacturing
Minimizing human error continues to be a challenge for both device and drug makers, even those that have successful quality programs. More frequent training doesn't seem to be the answer. In fact, studies show that lack of training is responsible for only about 10 percent of the human errors that occur. So what other options do you have to reduce human error in your organization? Take a step in the right direction by ordering this management report from FDAnews.

Drug/Device - Imports

Mastering the FDA's Import Rules
U.S. authorities are holding imports more than ever before, particularly at ports that have a history of holding products, and imports from India. This management report will tell you how to develop a top-notch import compliance program that will keep you in the "safe zone" when it comes to your dealings with the FDA and Customs. You'll gain a clear understanding of the FDA's expectations and qualifications and Customs' operational processes.

Drug/Device - Inspections

Equipment Maintenance, Calibration and Cleaning: A Guide to FDA Inspections
Problems with equipment maintenance, cleaning and calibration are among the FDA's most commonly observed deficiencies. This authoritative management report offers a comprehensive analysis of the FDA's regulatory requirements - and more importantly, strategies for complying and reducing risk while saving time and money.

Internal Auditing Basics: A Guide for Drug and Device Manufacturers
This brief demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements.

Investigations Operations Manual 2015
An investigation doesn't have to be full of surprises - as long as you know the rules that investigators will be operating under before they walk in the door. Know what the investigators look for - before they even get there. Know the investigators' expectations and rights. Find and fix problems before they end up on a Form 483 or warning letter.

Investigations Operations Manual 2016
Think like an investigator an FDA inspection doesnt have to be full of surprises. Dont wait for FDA investigators to tell you what their new focus is when theyre already at your facility. Go straight to the source. The Investigations Operations Manual is the primary policy guide for investigators and directs the conduct of all field investigation activities.

Investigations Operations Manual 2017
Think like an investigator an FDA inspection doesnt have to be full of surprises. Dont wait for FDA investigators to tell you what their new focus is when theyre already at your facility. Go straight to the source. The Investigations Operations Manual is the primary policy guide for investigators and directs the conduct of all field investigation activities.

Managing Data and Documentation for FDA Inspections
Do you understand the FDA's document access authority? Is your company's data and documentation organized and ready for your next FDA inspection? If not your next inspection could become a scavenger hunt and quickly turn into a nightmare. But that doesn't have to be the case. Managing Data and Documentation for FDA Inspections will teach you the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks.

Preparing for an FDA Preapproval Inspection
This book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed makeit to the marketplace.

Drug/Device - Liability

False Claims Act Liability: A Guide for Drug and Device Manufacturers
False Claims Act penalties are set to dramatically increase by nearly double. Violations of FDA requirements for promotion and marketing adverse event reporting or cGMPs can trigger the FCA. This management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers.

Drug/Device - Off-Label

The Impact of Off-Label Promotion on Product Liability
Your product is not approved for a particular use. You promote that product off-label, perpetuating the non-approved use. If patients are injured and become plaintiffs they could then argue that you failed to warn about the dangers associated with that particular use of the product. From a product liability standpoint, it will be nearly impossible for you to disclaim responsibility for warning about an off-label use. Here's the report that shows you how to minimize this risk.

Drug/Device - Physician Payment

Managing Physician Payment Disclosures: Compliance in the New Era of Transparency
This is the year that drug- and devicemakers will need to begin reporting - for the whole world to see - the types of financial arrangements they have with physicians and teaching hospitals. Planning for disclosure is one thing. Actually carrying it out will be another altogether. Are you ready for the host of challenges, headaches and questions that are about to land on your desk? This easy-to-read management report can set you on the right path in an hour or two of reading.

Drug/Device - Promotion

Advertising Drugs and Devices: Keys to FDA and FTC Compliance
This hands-on guide lays out the advertising landscape as the government sees it regulations, requirements, expectations and shows you the right road to take to compliance.

It's the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media
When the FDA reviews promotions It's not looking at how the information is being distributed. Rather, it looks at what information is being distributed. The agency focuses on violations in four general areas that could occur in digital, nontraditional and, of course, standard promotions. With this management report, you'll gain a clear understanding of what the FDA is watching NOW - and how to avoid enforcement action in the future.

Managing Product Pipeline Communications
When your company has a product in development, whether drug, device or biotech, what you can - and can't - say about it is tightly regulated by the FDA. At the same time, the SEC requires that information of material value to investors be properly disclosed to them. This management report will tell you how to balance these seemingly contradictory demands and how to handle all the forms "communication" takes today - from tweets to talking points, from press releases to the slides investors see on a conference call.

Promotional Communication: Keeping Up with FDA's Off-Label Use Policy
This report explores the draft guidances and other FDA activity on the subject of promotional communication, explaining what companies must do to stay on the right side of the agency's new policies and how to take advantage of the opportunities they present.

Social Media Accountability for Drug and Devicemakers: Controlling the Online Conversation
The FDA may not hold you responsible for reader comments, but they will watch for the way you respond. This management report gives you an understanding of how to use social media for product promotion without running afoul of the agency.

Social Media Strategies for Drug and Device Companies
No matter how fast the rules continue to change, this new management report will help drug- and devicemakers tap the power of social media. you'll find real-world strategies for building a strong presence on Facebook, Twitter and YouTube - without giving up control over your brand or risking marketing and advertising enforcement. With little specific guidance from the FDA, this report fills a critical gap.

Drug/Device - SOPs

Writing SOPs: Best Practices and Standard Operating Procedures
Your standard operating procedures are one of the first things FDA investigators will look at during an inspection. Yet, "inadequate SOPs" rank among the most-frequently cited Form 483 observations. This new management report will teach you the practical techniques you need for crafting well-written, fast-read, flexible and compliant SOPs - SOPs that will meet FDA requirements as well as today's globalized expectations.

Drug/Device - Spreadsheet Validation

Spreadsheet Validation 2015: Tools and Techniques to Make Data in Excel Compliant
This report details the best practices you need to create a spreadsheet validation plan, including: how to determine which spreadsheets actually need to be validated ; how to maintain control of your data in the cloud; how to incorporate a validation plan into your traditional QA processes; how to create test scripts to validate your spreadsheets; how to plan. And as a bonus, you'll also receive two white papers on spreadsheet design, verification and validation, and use and storage in single- and multiple-user environments.

Drug/Device - Sterile

Manufacturing Sterile Products to Meet EU and FDA Guidelines
In drug and device manufacturing, sterile means precisely what it says: The total absence of viable microorganisms. Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from its country's purity laws. Now's the time for a hard look at your manufacturing processes. This timely management report from FDAnews spells out how U.S. and EU manufacturers must handle sterile processing.

Drug/Device - Supplier Quality

24 Elements of a Successful Supplier Quality Agreement
Your agreements with suppliers must be written and executed to cover every possible contingency and ensure that the materials that go into your products are exactly what you require and are available when you need them. In this FDAnews Brief, 20-year industry veteran Steven Sharf, explains the elements that need to go into your quality agreement.

Drug/Device - Suppliers

Supplier Auditing: A Four-Part Plan
You need a supplier auditing program that helps you stay on top of all your outsourced operations. The FDAnews Brief Supplier Auditing: A Four-Part Plan helps you build a system that shows the FDA and other regulators that you hold the reins when it comes to supplier quality.

Clinical Books

Clinical - Adaptive Clinical Trials

Best Practices for Adaptive Clinical Trials: FDA Guidance and Philosophy
Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA's preferences, this report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.

Clinical - Adverse Event Reporting

Clinical Trials Adverse Event Reporting
This FDAnews bestseller is essential for clinical trial operators - the most up-to-date, comprehensive collection of rules, regulations and guidances available in a murky area where change happens fast. Get official OHRP and FDA answers to nagging questions with more than 200 pages of rules, regulations, interpretations and guidances.

Clinical Trials Adverse Event Reporting Guide - 2017 Edition
The completely revised and updated 2017 guide includes more than 300 pages of FDA guidance on adverse event reporting. Dont let your clinical trial fail just because you dont know the reporting rules. Theyre all in the guide.

Clinical - Audits

Strategies for Risk-Based Clinical Trials Monitoring and Inspections
You're probably on the fence about employing a risk-based clinical trial monitoring program. Many are, preferring the old methods of 100 percent verification of data - and intense site visits - that they're more familiar with. But the fact is risk-based monitoring with a centralized data monitoring component can actually produce better levels of compliance than the old ways - if it's done correctly. This FDAnews management report will show you exactly what 'done correctly' is.

Clinical - China

Conducting Clinical Trials in China: Overview of the Regulatory Landscape
The Chinese approach to GCP compliance and trial site licensing are unique. In addition, approval authorities, ethics committees, and the issues to consider in choosing investigators and trial locations must all reflect China's unique culture and regulatory structure. This report provides an overview of China's current regulatory landscape and points out key differences from US and European requirements. you'll also find practical advice for getting your applications and trials underway and keeping them compliant.

Clinical - ClinicalTrials.gov

ClinicalTrials.gov: Mastering the New Reporting Rules
This report parses out the 42 CFR Part 11, Final Rule for Clinical Trials Registration and Results Information provisions, explaining who must report what, what information you must submit, what the deadlines are and what could happen if you miss the mark.

Mastering New Reporting Rules for ClinicalTrials.gov
Major changes are coming soon that affect how drugmakers report the details of clinical trials on ClinicalTrials.gov. For example, sponsors will now have to submit outcomes data for any trial covered by an IND or BLA, even those not approved by the FDA. And that's just the tip of the iceberg. With this report, you'll learn what to do to be sure your regulatory affairs and clinical trial management teams are ready and compliant with the new rules once they're finalized.

Clinical - Compliance

Clinical Trial Compliance Guide: FDA Requirements
This is your searchable, one-stop source of all the FDAs clinical trial-related guidances.

GLP Compliance Strategies: 10 Steps to an Audit-Ready Lab
What would FDA inspectors say if they walked into your lab today and looked at your training records? Are your SOPs up-to-date and complete? Would your sample-handling procedures and archives win praise from an auditor? If you have any doubts, now is the time to take action with this management reports 10-step approach to ensuring quality in GLP-compliant labs

Human Subjects Questions, FDA Answers
FDAnews staff has culled through hundreds of questions submitted to the FDAs Office of Good Clinical Practice and curated more than 100 of the most relevant responses regarding human research subjects for you segmented by category.

Managing Clinical Investigator Compliance: A Guide to the FDA Requirements
This new report covers the specific responsibilities FDA has now given sponsors to see that investigators Don't cut corners during a clinical trial. you'll get a complete overview of the core requirements of the FDA "investigator responsibilities" guidance, learn what training is required for any and all staff involved in clinical trials, find out which investigator tasks must be performed by medically qualified staff, and much more.

Clinical - Consent

Implementing e-Consent for Clinical Trials
The simple fact about electronic informed consent is that it's much more than a digital handwritten signature. This management report will provide you with checklists and guides that will help you make an informed decision about the software that's best for you, as well as prepare you to talk to prospective vendors. Changing over to an e-consent system is probably not far away in your future.

Informed Consent for Clinical Trials 2015: A Regulatory Reference Guide
What can go wrong with informed consent documents? Plenty. Is your informed consent process effective and compliant with FDA and OHRP regulations? With this 300+ page guide, you will never again wonder if your informed consent process meets federal standards. Don't roll the dice and "hope" you will get this right - the stakes are too high. Make SURE you know, exactly, what's required to the letter.

Informed Consent for Clinical Trials: A Regulatory Reference Guide - 2017 Edition
The rules of the clinical research game are about to change. Are you ready? FDAnews updated edition explains the changes that are coming and gives you all the resources you need to comply with informed consent rules all in one place.

Obtaining Consent in International Clinical Research: Key Considerations
More than 60 percent of clinical studies submitted to CDER contain data from foreign study sites. Researchers need to be aware of the cultural differences, legal and regulatory requirements – and international guidelines – dictating principles for obtaining informed consent. Get prepared to adapt global informed consent templates to local country requirements.

Clinical - Data Integrity

Data Integrity in Clinical Trials: Ensuring Valid Results
Are you ready for the FDAs laser focus on your clinical trials data integrity? This management report details the challenges of maintaining data integrity in clinical trials and offers solutions for closing gaps that can lead to tainted results.

Clinical - Financial Disclosure

Guide to the FDA's Financial Disclosure Requirements for Clinical Investigators
The new FDA rules are subtle and complex. For example, while the agency doesn't bar all conflicts of interest, it does demand they be properly managed. While most types of financial disclosure are required, certain types are not. Some rules on reporting and conflict-of-interest mitigation are new, others remain unchanged. This management report covers all of these issues and more.

Clinical - Good Practices

GCP Enforcement Trends
From January 2010 through June 2015, the FDA issued 89 warning letters to clinical investigators, sponsors and IRBs for good clinical practices (GCP) violations. If you read all 89 one by one, you would find them to be compelling reading. But, the real power of the warning letters comes from looking at them closely as a 5+ year continuum. With the report in hand, you'll quickly become aware of the FDA's priorities and learn to recognize inspection red flags that almost always lead to GCP violations.

GCP Qualification Audits: Choosing Quality Contractors and Sites
In this report, Michelle Sceppa a GCP consultant with more than 25 years of experience in quality assurance and regulatory compliance lays out her approach to evaluating and selecting the best, most compliant and highest quality contractors to give your trial the best shot at success.

GCP Questions, FDA Answers
This collection of more than 175 questions submitted by clinical research professionals to the FDAs Office of Good Clinical Practice sheds light on some of the most difficult and important topics in clinical trial research.

Good Clinical Practices: The New ICH E6 Standard
Many clinical trial operators are struggling to master the complexities of the revised ICH E6. This report outlines the changes in the guideline and offers suggestions for implementing new requirements.

Clinical - Inspections

Clinical Investigator Questions, FDA Answers
What kinds of payments to investigators must be disclosed on a Form 3455? Which authority FDA, IRB or trial sponsor collects Form 1572s and financial disclosure statements? FDAnews staff has culled through questions submitted to OGCP about investigators and curated more than 90 of the most relevant responses. This collection sheds light on some of the most difficult and important topics in clinical trial research.

Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices
This report will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDAs requirements. You'll get specific recommendations about the 5 data points that you must always monitor 9 essential critical risk factors your monitoring plan must consider 5 key components that should make up your monitoring plan (and what they each should contain) and all of the documentation requirements that are absolutely essential to every monitoring plan.

Clinical - Observational Studies

Observational Studies: Opportunities and Challenges for Drug and Devicemakers
In this report based upon a webinar given by Jeff Trotter, a 30-year industry veteran, you will learn everything you need to know about the opportunities and pitfalls that observational studies can offer your organization. Drawing on a survey of more than 2,500 individuals representing a cross-section of the pharmaceutical, medical device and biotech industries, he discusses how companies are using observational studies.

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
The report walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. It looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products.

Clinical - Pediatrics

Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules
Under a new FDA guidance, manufacturers getting ready to submit a New Drug Application or Biologics License Application must include data on potential use of the product in pediatric populations. But what exactly does the FDA want to see? Find out in this management report.

Clinical - Trial Recruitment

Using Social Media in Clinical Trial Recruitment
Today, one in five sponsors uses social media to engage, recruit, and retain subjects for clinical trials. And why not? Clearly, social media is increasingly where your prospective study subjects are going to be found. This report is designed to help unsure clinical trial recruiters put aside their concerns and go ahead with social media recruiting of trial subjects. And if you're already using social media, it's an opportunity to hear how other organizations are overcoming challenges and employing social media for increasingly successful recruitment.

CFRs

2016 - Parts 1-99 (FDA, General)
2016 - Parts 100-169 (FDA, Food for Human Consumption)
2016 - Parts 1300-End (DEA and Office of National Drug Control Policy)
2016 - Parts 170-199 (FDA, Food for Human Consumption)
2016 - Parts 200-299 (FDA, Drugs: General)
2016 - Parts 300-499 (FDA, Drugs for Human Use)
2016 - Parts 500-599 (FDA, Animal Drugs, Feeds and Related Products)
2016 - Parts 600-799 (FDA, Biologics; Cosmetics)
2016 - Parts 800-1299 (FDA, Medical Devices)

2017 - Parts 1-99 (FDA, General)
2017 - Parts 100-169 (FDA, Food for Human Consumption)
2017 - Parts 1300-End (DEA and Office of National Drug Control Policy)
2017 - Parts 170-199 (FDA, Food for Human Consumption)
2017 - Parts 200-299 (FDA, Drugs: General)
2017 - Parts 300-499 (FDA, Drugs for Human Use)
2017 - Parts 500-599 (FDA, Animal Drugs, Feeds and Related Products)
2017 - Parts 600-799 (FDA, Biologics; Cosmetics)
2017 - Parts 800-1299 (FDA, Medical Devices)

Parts 1-99 (FDA, General)
Parts 100-169 (FDA, Food for Human Consumption)
Parts 1300-End (DEA and Office of National Drug Control Policy)
Parts 170-199 (FDA, Food for Human Consumption)
Parts 200-299 (FDA, Drugs: General)
Parts 300-499 (FDA, Drugs for Human Use)
Parts 500-599 (FDA, Animal Drugs, Feeds and Related Products)
Parts 600-799 (FDA, Biologics; Cosmetics)
Parts 800-1299 (FDA, Medical Devices)