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

• Good Review Procedures  (MaPP)

• Good Review Management Principles and Practices (GRMPs)  (Guidance)

Biometrics

• Biostatistics Biologics Licensing Application Review Template  (MaPP)

• Biostatistics New Drug Application Review Template  (MaPP)

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

• Clinical Pharmacology and Biopharmaceutics NDA Review Template  (MaPP)

• Exposure Response Relationships- Study Design, Data Analysis and Regulatory Applications  (Guidance)

• Integration of Study Results to Assess Concerns About Human Reproductive and Developmental Toxicities (draft)  (Guidance)

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

• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
• Drug Safety Information - FDA's Communication to the Public
• NDAs: Preapproval Safety Conferences (MaPP)
• Risk Management Plan Activities in the Office of New Drugs and the Office of Drug Safety (MaPP)