Good Review Practices (GRPs)

A Good Review Practice, or GRP, is a “documented best practice” within CDER that discusses any aspect related to the process, format, content and/or management of a product review.  GRPs are:

  • developed over time as superior practices based on experience, and provide consistency to the overall review process of new products

  • developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management

  • adopted by review staff as standard processes through supervisor mentoring, implementation teams and formal training when necessary

As GRPs develop, review staff will adopt them into their daily review activities. Since GRPs can change and evolve frequently as a result of new science, statutes, regulations, guidances, and accumulated experience, the policies will be updated regularly.   

Review staff are expected to follow GRPs and may depart from them only with appropriate justification and supervisory concurrence.

The GRP initiative is a true collaborative effort between many Offices within CDER. 

General / Review Management


Chemistry, Manufacturing and Controls


Clinical Pharmacology

Nonprescription Products



More in Guidance, Compliance & Regulatory Information

Good Review Practices (GRPs)

Page Last Updated: 12/12/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English