Draft Guidance for Reviewers and Industry on Good Review Management Principles for Prescription Drug User Fee Act Products; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for reviewers and industry entitled "Good Review Management Principles for PDUFA Products."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). The good review management principles (GRMPs) are intended to promote efficient and consistent management of application reviews. The GRMPs focus on the role of both reviewers and industry, emphasizing effective communication to enhance the drug development and review processes.