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GUIDANCE DOCUMENT

Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications Guidance for Industry and Review Staff September 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide recommendations to industry and review staff on good 21 review management principles and practices (GRMPs) for the review of new drug applications 22 (NDAs), biologics license applications (BLAs), or efficacy supplements/supplements with 23 clinical data.2 This guidance applies to human drug applications (as defined in section 735(1) of 24 the Federal Food, Drug, and Cosmetic Act (FD&C Act)) and biosimilar biological product 25 applications (section 744G(4) of the Public Health Service Act (PHS Act)). The goal of GRMPs 26 is to ensure that the review process is managed in a consistent and efficient manner, thereby 27 decreasing the number of review cycles necessary for approval and enhancing patients’ timely 28 access to important therapies. This guidance also clarifies the roles and responsibilities of 29 review staff in managing the review process and identifies ways in which applicants may support 30 an efficient and robust review process. Successful implementation of the GRMPs is crucial to 31 FDA’s mission of protecting and promoting the public health.3


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.