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Pre-Approval Inspection: Four Steps to Success

Pre-Approval Inspection: Four Steps to Success

December 9, 2019
This FDAnews Brief gives you a concise, point-by-point map to follow to pre-approval success, from developing an inspection SOP to making logistical decisions to handling investigators questions effectively, and surviving the data integrity audit.
Observational Studies: Opportunities and Challenges for Drug and Devicemakers

Observational Studies: Opportunities and Challenges for Drug and Devicemakers

December 9, 2019
In this report based upon a webinar given by Jeff Trotter, a 30-year industry veteran, you will learn everything you need to know about the opportunities and pitfalls that observational studies can offer your organization. Drawing on a survey of more than 2,500 individuals representing a cross-section of the pharmaceutical, medical device and biotech industries, he discusses how companies are using observational studies.
Obtaining Consent in International Clinical Research: Key Considerations

Obtaining Consent in International Clinical Research: Key Considerations

December 9, 2019
More than 60 percent of clinical studies submitted to CDER contain data from foreign study sites. Researchers need to be aware of the cultural differences, legal and regulatory requirements … and international guidelines … dictating principles for obtaining informed consent. Get prepared to adapt global informed consent templates to local country requirements.
Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?

Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean?

December 9, 2019
The FDA has historically taken a firm, restrictive stance on drugmakers communications about off-label uses of their products. Now, with the FDA settlement agreement with Amarin, other drugmakers are wondering what this means for them. Is this an Amarin onlyŽ issue or does it have broader implications
Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014

Perfecting Your Company Core Data Sheets: A Guide for Authoring and Updating the CCDS - 2014

December 9, 2019
Composing a Company Core Data Sheet (CCDS) is one of the toughest challenges facing drugmakers today. The CCDS is the prime reference document for every one of your drugs or biologics - the central document regulators and resellers rely on to label and manage the drug's use. what's the best way to correctly handle these essential documents? Make sure you're up to speed with the authoritative report from FDAnews.
Mobile Medical Apps: Keeping Up with the FDAs Evolving Requirements

Mobile Medical Apps: Keeping Up with the FDA's Evolving Requirements

December 9, 2019
Just because an app is running on an unregulated phone or tablet doesnt mean that the app itself isnt a medical device in the FDA's eyes. Where does the agency draw the line between unregulated products and those it must approve? This management report explains what the FDA means by enforcement discretion and how it considers an apps intended use in category assignment.
Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers

Navigating HCT/P Regulations: Risks and Opportunities for Drug and Device Manufacturers

December 9, 2019
The regenerative medicine industry is rapidly growing and, with major court decisions, new and significant FDA guidance, and government enforcement actions, the regulatory landscape is more complex than ever. With this management report, you will learn what uses of human cells and tissue are regulated and when the FDA requires an HCT/P to go through the marketing approval process.
Navigating Off-Label Device Promotion: How Will FDA Settlements Impact Devicemakers?

Navigating Off-Label Device Promotion: How Will FDA Settlements Impact Devicemakers?

December 9, 2019
The FDA has historically taken a firm, restrictive stance on communications about off-label uses of products. But the agencys position has become increasingly uncertain as the courts address the subject of freedom of commercial speech.Ž Will the recent decisions in the Amarin and Pacira cases open the door for devicemakers to broaden their communications?
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?

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