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Medical Device Inspections Guide 2016

Medical Device Inspections Guide 2016

December 9, 2019
Do you prepare your medical device facility for an FDA inspection the same way you did last year — or even six months ago? If you do, you need to rethink that. FDA inspections are getting tougher every day. You need to be well-versed in the regulations you must follow and the procedures the agency will use to conduct your inspection. This brand-new edition is a one-stop source for all the regulations, guidances and policies that impact medical device inspections.
Medical Device Mobile Apps: Meeting the FDA Requirements

Medical Device Mobile Apps: Meeting the FDA Requirements

December 9, 2019
With its guidance on apps, the FDA declared health-related apps fall under its jurisdiction - just like any software that is intended to assist in diagnosing or treating an illness. That means developers of health-related mobile apps for use on tablets and smartphones need to assess their apps to determine if FDA views them as a medical device. And, if it does, what the regulatory obligations are. With this management report your mHealth project will stay on schedule and in compliance.
Medical Device Recall or Product Enhancement?: Understanding the FDA's Part 806 Guidance

Medical Device Recall or Product Enhancement?: Understanding the FDA's Part 806 Guidance

December 9, 2019
Based on the FDA's most recent recall guidance, devicemakers now have to wonder if their product enhancements are: an acceptable product enhancement; a recall; a product enhancement that's now considered a recall; or neither a product enhancement nor a recall. This new management report provides the keys to unlocking a balance between expectations and your current product enhancement activities.
Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806

Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806

December 9, 2019
Under 21 CFR Part 7, you are requested to report corrections or removals to your FDA District Recall Coordinator promptly. But under 21 CFR Part 806, you are required to report within 10 business days after initiating such corrections or removals. Not only are devicemakers running afoul of the FDA on this point, they're likely to under-report field actions by misinterpreting Part 806. When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies?
Mastering the FDA's Import Rules

Mastering the FDA's Import Rules

December 9, 2019
U.S. authorities are holding imports more than ever before, particularly at ports that have a history of holding products, and imports from India. This management report will tell you how to develop a top-notch import compliance program that will keep you in the "safe zone" when it comes to your dealings with the FDA and Customs. You'll gain a clear understanding of the FDA's expectations and qualifications and Customs' operational processes.
MD Regulation in the EU vs US: Recent Revisions and Key Differences

MD Regulation in the EU vs US: Recent Revisions and Key Differences

December 9, 2019
Despite years of harmonization talks, the EU and U.S. still follow very different marketing approval processes. When the EU's MDD went into effect in 2010, those differences became even more pronounced. Failing to know the differences could handicap your time to market and ability to operate efficiently; failing to comply with them could shut you out of EU markets completely. This management report will help you get your medical devices into both U.S. and EU markets - without risking noncompliance nightmares in either.
Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

December 9, 2019
Both the FDA and ISO have specific requirements for calibrating medical devices. Devicemakers doing business in the US and abroad need a clear path to compliance if they want to avoid penalties. This brief provides a roadmap that walks devicemakers through each aspect of calibration requirements and explains how to combine them to endure full compliance.
Managing the Drug Supply Chain: Best Practices

Managing the Drug Supply Chain: Best Practices

December 9, 2019
This all-new management report from FDAnews helps you keep tabs on suppliers from Boston to Bangladesh. Supplier qualification and quality agreements. Timely and effective audits. These are but two of the dozens of key topics covered in Managing the Drug Supply Chain: Best Practices. You'll discover procedures you can implement now that ensure the strength of each supply-chain link for years to come.
Manufacturing Sterile Products to Meet EU and FDA Guidelines

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

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

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

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.

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