For Industry
Independent Evaluation of FDA's First Cycle Review Performance –- Final Report
Printable version (614 KB PDF)
July 16, 2008
Prepared by Booz Allen Hamilton Inc.
Prescription Drug User Fee Act III – Initiatives & Evaluations
Contract No. 223-04-8100 Task No. 3
TABLE OF CONTENTS
STUDY OVERVIEW
Objectives and Scope
Study Cohorts
Methodology
FINDINGS
Product and Disease Characteristics
GRMPs Compliance
Issues and Communication
Sponsor Characteristics
FDA Characteristics
APPENDIX A: GRMPS IMPLEMENTATION STATUS
GRMPs Compliance Baseline
GRMPs Compliance for FY 2005 to FY 2007 Products
APPENDIX B: SPONSOR AND FDA FOCUS GROUP FINDINGS
EXHIBITS
Exhibit 2. Overview of Study Cohorts and Data Sources
Exhibit 3. Data Gathering and Analysis Methodology
Exhibit 4. Drivers and Hypotheses of Multi-Cycle Reviews
Exhibit 5. Overview of Data Sources
Exhibit 6. Product Application Cohorts, Data Sources, and Analyses
Exhibit 7. Cohort Product Status and Approval Rates
Exhibit 8. First Cycle Approval Rate for Overall Study Cohort by Year
Exhibit 9. Approval Rate vs. Novelty and Indication
Exhibit 10. Special Development and Review Programs
Exhibit 11. First-Cycle Approval Rate by Application Type
Exhibit 12. GRMPs Phases and Activities
Exhibit 13. First Cycle Approval Rate by GRMPs Compliance
Exhibit 14. First Cycle Approval Rate by GRMPs Compliance and Review Designation
Exhibit 15. GRMPs Compliance and FDA-Sponsor Communication Frequency and Early Communication Timing
Exhibit 16. Overview of FDA-Sponsor Communications
Exhibit 17. Effect of End of Phase 2 Meetings on Approval Rate for FY2005-FY2007 Cohort
Exhibit 18. Effect of Pre-NDA/BLA Meetings and Timing on Approval Rate for FY2005-FY2007 Cohort
Exhibit 19. Incidence of Pre-NDA/BLA and EOP2 Meetings
Exhibit 20. Filing Review Issues Identified by Year
Exhibit 21. Impact of Issue Identification in Filing Review Notification for FY2002-FY2007 Cohort
Exhibit 23. Approvability Impact of 74-Day Letter Issues
Exhibit 24. FDA-Sponsor Communications for FY2005-FY2007 Cohort
Exhibit 25. Communication Type for FY2005-FY2007 Cohort
Exhibit 26. Amendments Submitted for Applications for FY2005 Products
Exhibit 27. Types of Amendments Submitted for FY2005 Applications
Exhibit 28. Advisory Committee Meetings and Review Designation
Exhibit 29. Advisory Committee Meeting Timing and Priority/Standard Designation
Exhibit 30. Impact of Major Issues Identified on Approval Rate in FY2005-FY2007 Cohort
Exhibit 33. Examples of Issues Observed by Category
Exhibit 34. Products with Postmarketing Study Commitments in FY2002-FY2007 Cohort
Exhibit 35. Distribution of PMCs for Single- and Multi-Cycle Approvals
Exhibit 36. Focus Area of Postmarketing Study Commitments for FY2002-FY2007 Cohort
Exhibit 37. Single-Cycle Approval Rate by Sponsor Experience
Exhibit 38. Sponsor Experience and Impact of Pre-Submission Meetings
Exhibit 39. Cumulative Average First Cycle Communications During Review Period by Sponsor Experience
Exhibit 40. Approval Rate vs. Sponsor Type and Origin
Exhibit 41. First Cycle Approval Rate by Review Designation and Company Size
Exhibit 42. Deficiencies in Multi-Cycle Products by Sponsor Size in FY2005-2007
Exhibit 43. Cumulative Average First-Cycle Communications During Review Period by Company Size
Exhibit 44. Cohort Applications by Office and Review Designation
Exhibit 45. Submission Timing and First Cycle Approval Rates
Exhibit 46. Staffing Changes Between Pre-Submission and Review
Exhibit 47. Impact of Foreign or Domestic Manufacturing Site
Exhibit 48. Summary Overview of Recommendations
Exhibit 49. Baseline of GRMPs Practices Adopted by Divisions – January 2006 Snapshot
Exhibit 50. GRMPs Compliance by Product
Exhibit 51. CDER and CBER GRMPs Compliance by Office
Exhibit 52. GRMPs Compliance in Review Phase
Exhibit 53. GRMPs Compliance in Filing and Action Phases
Exhibit 54. Review Communication Practices Preferred by Industry and FDA Focus Group Participants
Exhibit 55. Industry and FDA Focus Group Feedback on GRMPs Filing and Planning and Review Activities