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U.S. Department of Health and Human Services

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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

EXECUTIVE SUMMARY

STUDY OVERVIEW
Objectives and Scope
Study Cohorts
Methodology

FINDINGS
Product and Disease Characteristics
GRMPs Compliance
Issues and Communication
Sponsor Characteristics
FDA Characteristics

RECOMMENDATIONS

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

APPENDIX C: STUDY HYPOTHESES

EXHIBITS

Exhibit 1. Study Objectives

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 22. Applications with All Filing Review Issues Resolved by Action Date for FY2005-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 31. Major Deficiencies Cited in First Action Letter of Multi-Cycle Applications by Category for FY2002-FY2007 Cohort

Exhibit 32. Major Deficiencies Cited in First-Cycle Action Letter of Multi-Cycle Applications by Area for FY2002-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

Exhibit 56. Industry and FDA Focus Group Feedback on GRMPs Advisory Committee, Action and Post-Action Phases