The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.
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 ...
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
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.
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. @ ...
Australia@s Therapeutic Goods Administration (TGA) is holding a consultation into maggots used in the treatment of chronic and non-healing wounds.
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 ...
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 ...
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 ...
A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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