The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

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 ...

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 US Food and Drug Administration@s (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the ...

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.

Australia@s Therapeutic Goods Administration (TGA) is holding a consultation into maggots used in the treatment of chronic and non-healing wounds.

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

Learning Objectives Understand how to design strategic, phase appropriate regulatory pathways Participants will learn to anticipate data needs, identify risks early, and align development plans with ...

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 ...

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 ...

The International Council for Harmonisation (ICH) has endorsed the eCTD @ the electronic common technical document @ as the message standard for electronic submissions. This article presents an ...