This webcast will introduce the audience to the Use-Related Risk Analysis (URRA), a specific risk management document/tool used exclusively in the human factors validation programs for FDA ...

BALTIMORE @ The US Food and Drug Administration (FDA) will consider several factors when determining whether to accept real-world data (RWD) and real-world evidence (RWE) in regulatory submissions, ...

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 ...

The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in ...

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.

In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...

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 ...

This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.

ROTTERDAM, NETHERLANDS @ A panel of experts at RAPS@ European Digital Technology and Software Conference on Thursday urged regulatory professionals to embrace artificial intelligence (AI). They said ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. @ ...

Join us for a networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership roles.

Study Design Essentials for Regulatory Affairs: From Single-Arm to Bayesian Adaptive Join the RAPS Twin Cities Chapter for an engaging and practical session focused on understanding clinical study ...