US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way
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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New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.
Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.