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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.

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 Devicemakers 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.

Its 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.

Japans 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.