About: PDUFA date

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In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions.

Property	Value
dbo:abstract	In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions. (en)
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dbo:wikiPageWikiLink	dbr:Prescription_Drug_User_Fee_Act dbr:New_Drug_Application dbr:Approved_drug dbr:Clinical_trial dbr:Complete_Response_Letter dbr:Pharmaceutical_industry dbr:Food_and_Drug_Administration dbc:Pharmaceutical_industry dbc:Food_and_Drug_Administration dbc:Pharmaceutical_regulation_in_the_United_States dbc:Regulation dbr:Biologics_license_application dbr:Food_and_Drug_Administration_Reauthorization_Act
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rdfs:comment	In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions. (en)
rdfs:label	PDUFA date (en)
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