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Good Review Practices CDERUS FDA

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GRPs also provide an overall quality systems approach to product review ... Review of a New Product Application and Preparing a Report on the Review (Guidance) ... – PowerPoint PPT presentation

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Title: Good Review Practices CDERUS FDA


1
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

2
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

3
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
4
CDERs GRP Fundamental Values
  • Quality
  • Efficiency
  • Clarity
  • Transparency
  • Consistency

5
Quality
  • Consistent implementation of GRPs by review staff
    will enhance the quality of reviews, the review
    process, and the resultant regulatory action

6
Efficiency
  • GRPs will improve the efficiency of the review
    process through standardization.

7
Clarity
  • GRPs support clarity throughout the review
    process, including critical review and decision
    making prior to a regulatory action

8
Transparency
  • Developing and documenting GRPs ensures that
    CDERs review processes are readily available to
    both sponsors and the American public

9
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

10
GRPs also provide an overall quality systems
approach to product review
11
Quality Systems Approach
12
Quality Systems Approach to GRPs
13
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

14
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15
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16
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

17
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

18
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

19
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

20
  • Thank You
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