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Business · 04/11/2013Updated: 10/17/2026 · 1 min read

FDA Proposes Rule to Require Manufacturers to Notify of Permanent Discontinuance or Interruption in Manufacturing of Certain Drugs or Biological Products

The FDA is proposing a rule that would require manufacturers of certain drugs or biological products to notify the agency electronically of a permanent discontinuance or interruption in manufacturing that may lead to a shortage of the product in the US, affecting blood or blood component transfusions.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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