United States: Why, Who, When, Where And More: New Draft Guidance On Notifying FDA About Discontinuance Or Interruption In Manufacturing - Hyman, Phelps, & McNamara

United States: Why, Who, When, Where And More: New Draft Guidance On Notifying FDA About Discontinuance Or Interruption In Manufacturing - Hyman, Phelps, & McNamara

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On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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