Drugs

Good Review Practices (GRPs)

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. Titles of GRP MaPP and Guidance documents within CDER are listed below.  The most up to date documents can be found on the FDA Guidance Documents and CDER Manual of Policies & Procedures (Mapp) search pages.  

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

  • Good Review Practices (MaPP)
  • Good Review Management Principles and Practices for PDUFA Products (Guidance)
  • Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics (MaPP)
  •  Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited Review (MaPP)
  • Best Practices for Communication Between IND Sponsors and FDA During Drug Development  (Guidance)
  • NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (MaPP)

Biometrics

  • Good Review Practice: Statistical Review Template (MaPP)

Clinical

  • Good Review Practice:  Clinical Consultative Review of Drugs Regulated Within OND (MaPP)
  • Good Review Practice: Clinical Review Template (MaPP) (See Attachment B)
  • Good Review Practice: Good Review Management Principles and Practices for Effective IND  Development and Review (MaPP)
  • Good Review Practice: Clinical Review of Investigational New Drug Applications (MaPP)
  • Good Review Practice: Refuse to File (MaPP)
  • Premarket Risk Assessment  (Guidance)
  • Evaluating the Risks of Drug Exposure in Human Pregnancies (Guidance)

Clinical Pharmacology

  • Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (MaPP)
  • Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (Guidance)
  • Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns (Guidance)

Nonprescription Products

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

Safety

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

Chemistry, Manufacturing, and Controls


Pharmacology/Toxicology
 

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Good Review Practices (GRPs)

Page Last Updated: 02/13/2017
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