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.

LOGIN

BUY NOW 1-Year Unlimited Access $997

 

Search by keyword (title of book maybe) or simply scroll through the list of titles to find what you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Quality Risk Management for Pharmaceuticals

Quality Risk Management for Pharmaceuticals

December 9, 2019
Drugmakers must have an effective quality system. However, a basic quality system that just covers the GMP requirements is no longer good enough. This management report will tell how QRM can be applied both proactively and reactively and explore the potential application of QRM during the different phases of the product lifecycle.
Preparing for the EU GMP Inspection

Preparing for the EU GMP Inspection

December 9, 2019
The FDA's GMPs and the EU's GMPs are supposed to be harmonized. Supposed to be. The reality is there are subtle but significant differences between the two. This new handbook from FDAnews tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections. FDAnews reached out to four authorities on European drug manufacturing quality for their expertise. The result is a handbook you'll refer to whenever the EU inspectors come to call.
Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

Preparing the New Drug Application: Managing Submissions Amid Changing Global Requirements

December 9, 2019
This book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed make it to the marketplace.
Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

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

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

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

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

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.

Upcoming Events

Featured Products

Featured Stories

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More