Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing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. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.
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