FDAnews Books Library

 

Gain Access to All Books and Reports

Our Books Library gives you year-round unrestricted access to all our books and reports.

They can be accessed, searched, downloaded and read anywhere, anytime. Topics covered include inspections, auditing, validation, recalls, pharmacovigilance, biosimilars, adverse events, QSR Data, supply chain, financial disclosure requirements and much more. You’ll automatically receive every new book we publish — we'll send you notifications to alert you of each new book in the library.

LOGIN

BUY NOW Single-User 1-Year Unlimited Access $997

Also available: Take advantage of our multi-user and site licenses of the FDAnews Books Library so you’ll have the most-informed workforce! Contact James DeFalco, Sales Director at jdefalco@wcgclinical.com or +1 703.538.7638 to receive a custom quote.

Search by keyword (title of book maybe) or simply scroll through the list of titles to find what you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Social Media Strategies for Drug and Device Companies

Social Media Strategies for Drug and Device Companies

December 9, 2019
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.
Special Protocol Assessment: Winning FDA Support for Trial Design

Special Protocol Assessment: Winning FDA Support for Trial Design

December 9, 2019
A new FDA draft guidance gives drug sponsors detailed advice on how to take advantage of the opportunity to have agency staff review your protocol before you begin your trial.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 doesnt agree with your plans.
Strategies for Biosimilars Approval: A Map to 351(k) Success

Strategies for Biosimilars Approval: A Map to 351(k) Success

December 9, 2019
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.
Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

December 9, 2019
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 FDAs 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.
Root Cause Analysis for Drugs and Devices

Root Cause Analysis for Drugs and Devices

December 9, 2019
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.
Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

Smart Labeling Self-Audits: Prescriptions for Global Regulatory Compliance

December 9, 2019
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.
Regenerative Medicine: Steps to Accelerate Development

Regenerative Medicine: Steps to Accelerate Development

December 9, 2019
The Regenerative Medicine Advanced Therapy (RMAT) designation offers applicants an abbreviated pathway to approval, working closely with the FDA throughout the process. This report outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify.
Regulating Digital Health Tools: Understanding the FDAs New Guidances

Regulating Digital Health Tools: Understanding the FDA's New Guidances

December 9, 2019
Clinical decision support software … software as a medical device … artificial intelligence and machine learning — rapid developments in digital technology are blurring the line between FDA-regulated medical devices and unregulated "lifestyle apps." This report combs through the guidances and sets out the rules devicemakers must follow.
Regulatory Challenges of Device Acceptance

Regulatory Challenges of Device Acceptance

December 9, 2019
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.
Risk Management in Clinical Trials: The New ICH E6 Focus

Risk Management in Clinical Trials: The New ICH E6 Focus

December 9, 2019
When the International Council on Harmonisation (ICH) updated its good clinical practice guidance in 2016, it made major revisions to the section on sponsor responsibilities that emphasize the importance of risk-based thinking. In this report Dr. Susan Leister, Director of Quality Assurance at Technical Resources International, explains the significance of the new focus on risk management.
Process Validation: A Guide for Devicemakers

Process Validation: A Guide for Devicemakers

December 9, 2019
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.
Promotional Communication: Keeping Up with FDA's Off-Label Use Policy

Promotional Communication: Keeping Up with FDA's Off-Label Use Policy

December 9, 2019
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.

Upcoming Events

Featured Products

Featured Stories

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More