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- FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concernsFDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
- FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviewsThe U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…