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Drug Shortage Legislation Gains Momentum With Bipartisan House Bill

Executive Summary

Momentum is increasing for efforts to require manufacturers to give advance warning of a drug shortage with legislation now filed in both houses of Congress.

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

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.

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

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.

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