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FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

On Feb. 5, 2024, FDA announced it has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, to assist applicants and manufacturers in notifying the agency about changes in production of finished drug products, biological products, and APIs. The guidance is part of the agency’s efforts to prevent drug shortages. How FDA communicates with the public about drug shortages is also addressed in the document.

Notification of manufacturing interruptions are required under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s regulations.

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