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, HHS ...

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

The US Food and Drug Administration (FDA) on Tuesday announced a new framework for licensing COVID-19 vaccine boosters that would move away from the agency@s more universal approach to boosters to ...

In a scathing letter resignation letter, Peter Marks, the US Food and Drug Administration@s (FDA) top biologics regulator, said he is leaving the agency due to Health and Human Services (HHS) ...

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is ...

Uruguay@s top health official, Cristina Lustemberg, has sought dialogue with opposition-party lawmakers in an attempt to push forward a project to create a national medicines agency, which Uruguay ...

Developing pre-defined change control plans (PCCPS) for devices that leverage artificial intelligence and machine learning (AI/ML) requires significant effort and attention to detail, and companies ...

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

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

The US Food and Drug Administration (FDA) announced plans to implement AI tools throughout the agency to assist in conducting scientific reviews following the successful completion of a pilot program ...

The US Food and Drug Administration (FDA) on Tuesday announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that produce medical products and foods.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its wish list for the next European Union Multiannual Financial Framework (MFF), which will shape the region ...