Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing
FDA Law Blog
MARCH 4, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Early notification can play a role in decreasing the impact and duration of such supply disruptions and product shortages. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.
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