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US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way

Executive Summary

Longstanding compliance policy program aimed at getting marketed but unapproved drugs through the NDA/ANDA pathway is reinstated because its termination by the Trump Administration was ‘legally and factually inaccurate’; some experts want FDA to consider program’s impact on drug pricing as it re-establishes the initiative.

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