Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing
FDA Law Blog
MARCH 4, 2024
Early notification can play a role in decreasing the impact and duration of such supply disruptions and product shortages. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. FDA informs the public of both shortages and extended use dates to assist with drug shortages.
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