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Complex Generic Approval Delays Getting Congressional Attention

 
• By Derrick Gingery

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

Capitol Building, Washington DC
A bipartisan group of House Energy and Commerce Committee members want information from FDA on complex generic approvals, potentially to consider ways of streamlining the process.

Provisions in the upcoming user fee reauthorization bill may already be in development as a bipartisan group in the House of Representatives requested updates on the US Food and Drug Administration’s complex generic drug approval process.

A 17 January letter to FDA Commissioner Stephen Hahn from majority and minority leaders of the House Energy and Commerce Committee asks for information related to complex generic policies...

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