RAPS Euro Convergence unites regulatory affairs professionals and industry partners to share and collaborate on solutions for the improvement and advancement of healthcare in Europe.

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, more ...

The European Medicines Agency (EMA) has set out actions to improve scientific advice and accelerate regulatory processes in public health emergencies.

PROVIDENCE, RI @ A US Food and Drug Administration (FDA) official said that predetermined change control plans (PCCPs), while not required, can reduce the need to submit supplemental applications for ...

The American College of Gastroenterology (ACG) has urged the US Food and Drug Administration (FDA) to consider certain inclusion and exclusion criteria when asking sponsors to conduct clinical trials ...

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...

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

Industry, patient groups, and academics seek more clarity from the US Food and Drug Administration (FDA) regarding its plans to require drug and biologic manufacturers to update their labeling after ...

The European Artificial Intelligence (AI) Act is one of the most challenging new regulations facing manufacturers. The act introduces new concepts, like human oversight and data management, that ...

The US Food and Drug Administration (FDA) recently finalized guidance detailing the criteria it will use to evaluate waiver requests for pH adjusters submitted by sponsors of abbreviated new drug ...

RAPS Euro Convergence is a must-attend event for regulatory affairs professionals. Up to date insights from industry, excellent networking opportunities and a relaxed atmosphere - all contribute to a ...