Senate Prevails On PDUFA Antibiotic Incentive As House Vote Nears

House is expected to vote on the reconciled FDA user fee bill June 20. Negotiators picked Senate GAIN language, including its less prescriptive qualifying pathogen definition.

New antibiotic development incentives in the pending House/Senate FDA user fee bill use Senate language almost exclusively, including its less prescriptive definition of pathogens that should be targeted by manufacturers who want to receive the incentives.

It was a big victory for FDA and other stakeholders who in the final days of negotiations between the two chambers pushed hard for the Senate version of

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