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Drug Shortages Bill In Senate Would Increase Manufacturing Disclosures To FDA

Executive Summary

Drug makers would have to inform FDA about business decisions that could result in drug shortages, under legislation introduced Feb. 7 by Sens. Amy Klobuchar, D-Minn., and Robert Casey, D-Pa.

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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.

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