Good Review Practices (GRP)
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 in order to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams and formal training when necessary.
As GRPs develop, review staff need to be able to access them and 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, GRP policies are expected to be updated regularly.
Review staff are expected to abide by 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 (firstname.lastname@example.org), Quality Management Staff (QMS) at 301-594-5721.
General / Review Management
Biostatistics Biologics Licensing Application Review Template [PDF]
Chemistry, Manufacturing and Controls
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review [PDF]
Clinical Review Template [PDF]
NDA Filing Review Issues [PDF]
- Premarket Risk Assessment [PDF]
Evaluating the Risks of Drug Exposure in Human Pregnancies [PDF]
Clinical Pharmacology and Biopharmaceutics NDA Review Template [PDF]
Exposure Response Relationships- Study Design, Data Analysis and Regulatory Applications [PDF]
Integration of Study Results to Assess Concerns About Human Reproductive and Developmental Toxicities (draft) [PDF]