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Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

December 9, 2019

This report — authored by international GMP expert Thomas Peither and associates — lays out the basics of building a four-phase qualification plan that satisfies US and EU requirements.

Pharma Change Control: Strategies for Successful Company-Wide Implementation

December 9, 2019

Drugmaking processes change constantly. New companies enter the supply chain, old ones drop off. New production machinery and software supplant old stuff. Things get complicated and before you know it, your files are filled with new specifications and revised SOPs. But the FDA likes things simple, clear cut and well tracked. That leaves you a lot of questions. Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes.

Pharma Strategies in Latin America: Keys to Success

December 9, 2019

This report covers all you need to know about entering the Latin American market, from research and clinical trials to postmarketing surveillance.

Pharmacovigilance in the European Union: A Guide to New Directive

December 9, 2019

Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life. This report will help readers navigate the EU's complicated regulatory landscape and stay compliant.

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

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

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: Interpreting the FDAs Stance

December 9, 2019

The federal court ruling in Amarin allows drugmakers to make truthful statements about Vascepa. But what does that really mean? Find out in this management report.

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 only issue or does it have broader implications

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

December 9, 2019

Just because an app is running on an unregulated phone or tablet doesnt mean that the app itself isnt 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 apps intended use in category assignment.

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.