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Guidance Documents/Guidance-Document/Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

February 6, 2024

February 5, 2024

Center for Drug Evaluation and Research

4bb3edae-dd26-480a-a41b-2f2b6bd19311

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