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Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA's sterilization pilot. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical trials. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from IVDs and LDTs, developing SOPs and pharmaceutical quality risk management. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Over the past week, the FDA issued several documents, including a final guidance for testing drug components for diethylene glycol and ethylene glycol and the announcement of a discussion paper on AI. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More