2012, Medical and Supply Chain - Primary Care Digest

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2012

Medical

Supply Chain

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing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

Manufacturing

Manufacturing Supply Chain Provider Treatment Plan

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

APRIL 8, 2024

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. In Section I.A,

Supply Chain

Supply Chain Manufacturing Government Hospital

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

Does the Drug Shortage White Paper Fall Short?

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