Guidance for Review Staff and Industry on Good Review Management Principles and Practices for Prescription Drug User Fee Act Products; Availability

Resumo

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).