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Breakthrough-Style Program For ANDAs Added To House User Fee Bill

 
• By Michael Cipriano

Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.

The final user fee reauthorization bill could contain several mechanisms geared toward improving generic competition in the marketplace, with the House Energy and Commerce Committee's Subcommittee on Health most recently adopting an amendment that would create breakthrough therapy-like provisions for potential competitors where no generic exists.

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