This document provides guidance to industry and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on good review management principles and practices (GRMPs) for the conduct of the first cycle review of a new drug application (NDA), a biologics license application (BLA), or an efficacy supplement under the Prescription Drug User Fee Act of 1992 (PDUFA). The GRMPs in this guidance are based on the collective experience of CDER and CBER with review of applications for PDUFA products and are intended to promote the practice of good review management based on sound fundamental values and principles. This guidance also clarifies the roles and responsibilities of review staff in managing the review process and identifies ways in which NDA and BLA applicants may further the effectiveness and efficiency of the review process.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.