By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...
The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
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, ...
Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time ...
Three regulatory affairs professionals have been recognized as the 2026 RAPS Fellows. Each year, our society honors a new class of RAPS Fellows for their noteworthy and sustained leadership ...
The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement. FDA issued an ...
The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better ...
India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
This webinar will make the case for a global, holistic framework that captures overlapping and interdependent obligations through a coordinated strategy. Learn why managing trial disclosure by country ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. I ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
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