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FDA's Gottlieb Looks To Resuscitate Competition For Shortage Drugs

Executive Summary

FDA's new commissioner, Scott Gottlieb, is looking to go beyond the agency's ad hoc responses to sterile injectables drug shortages and find ways to prevent such shortages by stirring up more competition under Hatch-Waxman. Meanwhile, manufacturers are looking for deeper commitments from group purchasing organizations to buy such drugs, which would enable greater investments in facilities and equipment.

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