Good Review Practices CDERUS FDA

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Good Review Practices CDER/US FDA

• Justina A. Molzon M.S. Pharm., J.D.
• Associate Director for International Programs
• Center for Drug Evaluation and Research/USFDA

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GRPs are not New

• For more than a decade, CDER has engaged in
  various Good Review Practices initiatives
• Originally initiated at the request of David
  Kessler ( FDA Commissioner 19901997)
• GRPs were established to bring about the
  continuous enhancement of review practices
• Refinement
• Re-design
• Overall improvement

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History of Good Review Practices
Smart Program, DFS, EES, OTCOM Established
Reviews Evaluation Project - Draft ISS Guidance
1995
Reviews Evaluation Steering Group - renamed
Reviews Evaluation Education Project
1996
GRP Clusters 1-5 Begin
1997
Pharm/Tox Review Format -Draft-Guidance
1998
CTD Finalized
The Clusters 1 - Define Good Review 2 - Obtain
Buy-in 3 - Implementation 4 - Training 5 -
Impact/External Evaluation
2000
2001
Review Templates
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CDERs GRP Fundamental Values

• Quality
• Efficiency
• Clarity
• Transparency
• Consistency

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Quality

• Consistent implementation of GRPs by review staff
  will enhance the quality of reviews, the review
  process, and the resultant regulatory action

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Efficiency

• GRPs will improve the efficiency of the review
  process through standardization.

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Clarity

• GRPs support clarity throughout the review
  process, including critical review and decision
  making prior to a regulatory action

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Transparency

• Developing and documenting GRPs ensures that
  CDERs review processes are readily available to
  both sponsors and the American public

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Consistency

• By using an established and documented approach
  and only deviating from it when appropriate, GRPs
  help reviewers achieve consistency with their
  reviews and standardize review processes across
  divisions

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GRPs also provide an overall quality systems
approach to product review
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Quality Systems Approach
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Quality Systems Approach to GRPs
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CDER GRP Web Site

• All CDER Good Review Practices are now located on
  an FDA/CDER website
• http//www.fda.gov/cder/other/grp.htm

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Good Review Practices Manual of Policies and
Procedures (MAPP)

• Instruct review staff on what GRPs are
• Provides general policies, roles and
  responsibilities for all future GRPs

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Good Review Management Principles and Practices
for PDUFA Products (Guidance)

• Gives an ideal timeline for a first cycle NDA/BLA
  review
• Reflects expectations both FDA and sponsors as
  negotiated through PDUFA
• Details activities of various review disciplines
• Provides for better coordination of review
  process

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Conducting a Clinical Safety Review of a New
Product Application and Preparing a Report on the
Review (Guidance)

• Very detailed instructions on how reviewers
  should perform a safety review
• Offers philosophy of how to prioritize safety
  issues
• Concentrates on evaluating pooled safety data
  from the Integrated Summary of Safety (ISS), an
  FDA specific regulatory requirement

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In Summary, GRPs

• Provide a more consistent approach to the review
  and approval of new products
• Specify process, format and content of a review
• Standardize reviews and review management
• Train staff on the review process
• Inform industry and the public of CDERs internal
  review best practices and processes
• Provide an overall quality systems approach to
  product review

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• Thank You