Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU Medical Device Regulation (EU MDR) submissions, but there is limited guidance on survey procedure ...

The US Food and Drug Administration (FDA) has issued draft guidance on developing cancer drugs intended for use in combination with other therapies. The guidance focuses on demonstrating each drug's ...

Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA.

PDG said selection of the Korean Pharmacopoeia was a consensus decision that @reflects the quality of the Korean Pharmacopoeia@s application and its alignment with the PDG@s mission to promote global ...

This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Medical groups sue HHS, Kennedy over vaccine policy (Reuters) (NYTimes) US FDA approves KalVista's ...

To reduce the risk of aluminum toxicity in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

The US Food and Drug Administration evaluated most therapeutic devices granted breakthrough designation within established review goals, but according to recent research published in JAMA Internal ...

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, we ...

Working in regulatory affairs means becoming intimately familiar with a long list of regulations, laws, guidances, and acronyms. But that should not prevent you from focusing on the ultimate goal. "To ...

The future of the US Food and Drug Administration@s (FDA) involvement with laboratory-developed tests (LDTs) seems uncertain in the wake of a recent federal court case that successful overturned the ...

The US Food and Drug Administration (FDA) has announced that it will give drugmakers more time to conduct testing for nitrosamine drug substance-related impurities (NDSRIs) in approved pharmaceuticals ...