Good Review Practices

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FDA/Center for Drug Evaluation and Research

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.

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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

Good Review Procedures (MaPP)
Good Review Management Principles and Practices (GRMPs) (Guidance)

Biometrics

Chemistry, Manufacturing and Controls

Clinical

Consultative Review of Drugs Regulated Within OND (MaPP)
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Guidance)
Clinical Review Template (MaPP)
NDA Filing Review Issues (MaPP)
Premarket Risk Assessment (Guidance)
Evaluating the Risks of Drug Exposure in Human Pregnancies (Guidance)
Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (Guidance)

Clinical Pharmacology

Nonprescription Products

Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (MaPP)

Pharmacology/Toxicology

Pharmacology/Toxicology Review Format (Guidance)

Safety

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Date created: September 11, 2006, updated July 30, 2007