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Drug Shortage Provisions In Draft PDUFA Bill Would Expedite Major Manufacturing Changes

 
• By Cathy Dombrowski

FDA would have 60 days to review major changes and could “deem” them compliant with current good manufacturing practices so long as the facility has a plan and resources to achieve full compliance and institutes quality control measures under draft legislation being developed by the House Energy and Commerce Committee.

FDA could approve major manufacturing changes that may prevent or alleviate drug shortages even if those changes are not immediately compliant with current good manufacturing practices, under legislation being drafted by the House Energy and Commerce Committee to reauthorize the prescription drug and other user fee programs.

The draft bill, which is intended for discussion purposes, has a number of add-ons to the fees, including...

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