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

 
• By Sue Sutter

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.

not approved stamp
FDA may modify its unapproved drugs initiative as the agency revives it. • Source: Photo illustration/Alamy image

Reinstatement of the US Food and Drug Administration’s compliance policy governing marketed, unapproved drugs could provide an opening to rethink a program that has been lauded by some experts for its intent but criticized for its unintended consequences, including higher drug prices.

The Unapproved Drugs Initiative (UDI) is back, a mere six months after its termination was announced by the former Trump Administration’s Health and Human Services Department. (Also see "US...

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