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 Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 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.

Using Social Media in Clinical Trial Recruitment

Using Social Media in Clinical Trial Recruitment

December 9, 2019
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.
Using the MDSAP Model to Win International Device Approval

Using the MDSAP Model to Win International Device Approval

December 9, 2019
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.
Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

Winning Device EU Marketing Approval: Seven Steps to Writing Clinical Evaluation Reports

December 9, 2019
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 didnt 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.
Understanding the New EU Medical Device Regulations

Understanding the New EU Medical Device Regulations

December 9, 2019
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.
Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

December 9, 2019
Drug and device advertising, marketing and promotion are edging into some brave new worlds. Its not OK for creative teams to operate unaware of FDA and FTC rules and attitudes. This report takes a deep dive into six areas regulators give the most attention.
Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps

December 9, 2019
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.
UDI Direct Marking for FDA Compliance: Navigating New Rules

UDI Direct Marking for FDA Compliance: Navigating New Rules

December 9, 2019
Confused by the FDAs UDI direct marking regulations? What information should go on the label and the device itself? What methods of marking are acceptable? Jay Crowley, the go-to expert on UDI compliance and the architect of UDI while at the FDA, lays out a path to compliance in this FDAnewsBrief.
The Revised Common Rule: New Requirements for Clinical Trials

The Revised Common Rule: New Requirements for Clinical Trials

December 9, 2019
Two prominent healthcare attorneys sift through the new rule to mark out every deletion — highlight every addition — interpret every rewording — that clinical research professionals and institutions will need to understand to be compliant.
Tools for Faster Drug and Device Development: FDA's New Pathways to Innovation

Tools for Faster Drug and Device Development: FDA's New Pathways to Innovation

December 9, 2019
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.
The Drug Manufacturer's Guide to Site Master Files

The Drug Manufacturer's Guide to Site Master Files

December 9, 2019
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.
The FDA's New Inspection Practices: A Guide for Drugmakers

The FDA's New Inspection Practices: A Guide for Drugmakers

December 9, 2019
Your next inspection will not be like your last one! This management report explains the FDAs plans for upgrading its inspectorate and provides the key resources you will need to prepare for your next inspection.
The Impact of Off-Label Promotion on Product Liability

The Impact of Off-Label Promotion on Product Liability

December 9, 2019
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.

Upcoming Events

Featured Products

Featured Stories

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

Learn More