Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing
FDA Law Blog: Biosimilars
MARCH 4, 2024
Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.
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