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It's the Message, Not the Medium: Managing FDA Promotional Compliance Beyond Traditional Media

December 9, 2019

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.

Japan's New Fast-Track Pathway for Drugmakers

December 9, 2019

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.

Managing Clinical Investigator Compliance: A Guide to the FDA Requirements

December 9, 2019

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.

Managing Contract Manufacturers and Testing Labs

December 9, 2019

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.

Investigations Operations Manual 2018

December 9, 2019

An investigation doesnt 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.

ISO 13485:2016 - A Devicemaker's Transition Guide

December 9, 2019

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

December 9, 2019

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.

Investigations Operations Manual 2016

December 9, 2019

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

December 9, 2019

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 2015

December 9, 2019

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.

Implementing an 11-Step Plan for Device Software Validation and Verification

December 9, 2019

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

December 9, 2019

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.