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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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.