By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...
Editor's note: This article was updated on 7 May 2026 to correct the name of one of the organizations that commented on the guidance. The US pharmaceutical industry expressed support for the US Food ...
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, ...
The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. I ...
The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound ...
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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 ...
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. Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top ...
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