Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build ...

This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices. Its seven chapters are divided into three parts. Part I ...

Need help recalling and understanding regulatory concepts? RAPS has the tool for you, whether you are studying to take the RAC exam or you want to sharpen your knowledge of regulatory terminology.

Finding your way through the regulations, state-of-the-art standards, and interpretations applicable to health software, and, in particular, software as a medical device (SaMD), can be challenging.

Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems (QMS), with a focus on quality assurance, good manufacturing practice, good clinical ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, FDA ...

Medical device makers must comply with the US Food and Drug Administration@s (FDA) Quality Management System Regulation (QMSR) after the rule took effect on Monday. Additionally, FDA inspections of ...

BRUSSELS @ European Commission officials say they have proposed legislative changes to the European Parliament that they hope will ease regulatory requirements for sponsors of combined studies based ...

BRUSSELS @ Experts from the European Commission shed light on the proposed wide-ranging changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) that have been put ...

Biosimilar industry groups have expressed support for a recent guidance from the US Food and Drug Administration (FDA) that recommends the elimination of comparative efficacy studies (CES) for most ...

The US Food and Drug Administration@s (FDA) Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, representing a slight decrease from the novel approvals in recent years.

The US Food and Drug Administration (FDA) has announced it will take a flexible approach to reviewing all new cell and gene therapy (CGTs) biologics license applications (BLAs) to expedite the ...