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Over the past week, the FDA issued two final and three draft guidances, as well as requests for comments on several advisory committee meetings, user fees, IND applications and the agency’s data and technology strategic plan. In addition, CDRH released details of the center’s Radiation Sterilization Master File Pilot Program. Read More
Upcoming events in the coming weeks include nine 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