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Manufacturing Sterile Products to Meet EU and FDA Guidelines

December 9, 2019

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.

Mastering Batch Record Review

December 9, 2019

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?

Mastering New Reporting Rules for Clinicaltrials.gov

December 9, 2019

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.

Managing Nonconforming Product: A Devicemaker's Guide to Compliance

December 9, 2019

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.

Managing Physician Payment Disclosures: Compliance in the New Era of Transparency

December 9, 2019

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.

Managing Product Pipeline Communications

December 9, 2019

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.

Managing the Device Supply Chain: Best Practices

December 9, 2019

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!

Managing Contract Manufacturers and Testing Labs: 2016 Edition

December 9, 2019

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 Data and Documentation for FDA Inspections

December 9, 2019

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.

Managing Device Purchasing Controls

December 9, 2019

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.

Managing Effective CAPA Systems

December 9, 2019

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.

Managing HCT/Ps Under the FDA's New Guidelines

December 9, 2019

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.