Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny.

The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.

With the 20 Elements of Postmarket Reporting brief you will learn how to prepare Periodic Benefit-Risk Evaluation Reports (PBRER) in a modular format that can be used in other postmarket surveillance reports required by the FDA and international regulators.

This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016.

Follow the five-step plan in QSR-Compliant Purchasing Controls to avoid becoming part of that statistic. This FDAnewsBrief explains what the regulation requires and how to make sure your system passes muster.

The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen.