FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:
"The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the products in the United States.”"
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Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
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