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.  

And as an added bonus you’ll receive the most up-to-date editions of the FDA’s Code of Federal Regulations and its Investigations Operations Manual.

LOGIN

BUY NOW 1-Year Unlimited Access $997

 

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.

Device Complaint Management: A Practical Guide to Evaluating, Investigating and Reporting

June 10, 2020
The FDA expects you to know and react immediately to reports that your device might have put someone in danger. This report outlines all the factors you need to consider in handling complaints, how they interact and how to navigate through regulations.

Auditing for Quality Manufacturing: Five Areas of Risk for Drug and Device Manufacturers

May 6, 2020
This management report will help you prepare, organize and streamline your audit approach so you can identify quality issues to establish a more robust operation that stands up to regulatory scrutiny.

Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances

May 6, 2020
Complying with good manufacturing practices (GMP) is mandatory for your drug’s success – sampling, testing and packaging materials all need to meet stringent regulatory standards. Set yourself up for EU success with this management report.

Risk Management for Drug and Device Manufacturers: A Guide to FDA Policies and Processes

April 24, 2020
Without a good overview of the latest risk guidances, you may not know how to readily identify potential hazards, apply proper risk evaluation requirements or conduct pre- and postmarket assessments of your drug products and medical devices. This guide has more than 400 pages of FDA requirements and 20 specific documents that include guidances, statements and policies.

GCP Questions, FDA Answers - 2019 Edition

April 24, 2020
This collection of questions submitted to the FDA’s Office of Good Clinical Practice sheds light on some of the most difficult and important topics in clinical trial research.

The EU-MDR Transition: Meeting the CE Mark Deadline

April 24, 2020
This management report explains how to take advantage of what the EU is calling a “soft transition” to its new medical device regulation. It breaks down all the rules and explains all the implications of a soft transition, providing a path to follow to full compliance.

EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU GMP Guide

April 24, 2020
In this guide, you'll get a step-by-step walkthrough of the batch release process and what EU GMP guidelines apply, written by a recognized European GMP expert.

2019 - Parts 1300-End (DEA and Office of National Drug Control Policy)

April 24, 2020

2019 - Parts 800-1299 (FDA, Medical Devices)

April 24, 2020

2019 - Parts 600-799 (FDA, Biologics; Cosmetics)

April 24, 2020

2019 - Parts 500-599 (FDA, Animal Drugs, Feeds and Related Products)

April 24, 2020

2019 - Parts 300-499 (FDA, Drugs for Human Use)

April 24, 2020

Upcoming Events

Featured Products

Featured Stories

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

Learn More