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U.S. Department of Health and Human Services

Drugs

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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.  For additional information, please contact Lana Pauls (lana.pauls@fda.hhs.gov), Quality Management Staff (QMS) at (301) 443-5169.

General / Review Management

Biometrics

Chemistry, Manufacturing and Controls

 Clinical

Clinical Pharmacology

Nonprescription Products

Pharmacology/Toxicology

Safety