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Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Given the disruptions in supply that have continued to occur even beyond the end of the pandemic crisis, it is not surprising that FDA has issued a draft guidance on this subject.

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.