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Entreprise · 31/03/20051 min de lecture
Guidance for Review Staff and Industry on Good Review Management Principles and Practices for Prescription Drug User Fee Act Products; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of a guidance for review staff and industry entitled "Good Review Management Principles and Practices for PDUFA Products." This is one in a series of guidance documents that FDA agreed to draft and implement in conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA).
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →