For Industry

Postmarketing Commitments Study Final Report Text Version

Contract No. 223-04-8100 Task No. 4

Note: This version of the report was modified from its original format to accommodate Federal website Section 508 compliance requirements. To view the original format of the report, refer to the link to the PDF version of the document.


January 2008



1. Executive Summary

2. Background, Objectives, and Scope

2.1 Study Objectives
2.2 Study Scope

3. Methodology

4. Findings

4.1 Study Cohort Overview
4.2 PMC Development
4.3 PMC Rationale

4.3.1 Issue/Data Gap
4.3.2 Study Timing
4.3.3 Best Practices Observed

4.4 PMC Milestone Submission, Tracking and Review

4.4.1 Status of PMCs in Study Cohort
4.4.2 Factors Responsible for Delayed PMCs
4.4.3 PMC Tracking and Communication
4.4.4 Timeliness of Sponsor Submission and FDA Review
4.4.5 Best Practices Observed

4.5 Public Health Impact

5. Recommendations

5.1 PMC Development and Rationale Recommendations
5.2 PMC Tracking and Review Recommendations


Exhibit 3-1. High-Level PMC Study Approach
Exhibit 5-1: Sample PMC Development Template


Table 1: PMC Study Cohort by NDA/BLA and NME/non-NME Status
Table 2: Distribution of PMCs across BLAs and NDAs by NME/non-NME status
Table 3: Study Cohort Products and PMCs by Fiscal Year
Table 4: PMC Category Distribution
Table 5: PMC and Product Distribution by Division, Office, and Center
Table 6: Average Number of PMCs per Application by Division/Office
Table 7: PMC Development by GRMPs Phase
Table 8: Sponsor Involvement in PMC Development
Table 9: Factors that Influence FDA's Decision to Request a PMC
Table 10: Actual PMC Rationale for FY 2002-2005 Cohort
Table 11: Study Type Requested When Additional Data or Analysis Needed for Expected/Submitted Study
Table 12: PMC Study Rationale by Review Division
Table 13: Primary Rationale for Postmarketing Study Timing
Table 14: Influence of Product Review Factors on PMC Decision
Table 15: Status of PMCs
Table 16: Status of PMCs by Study Type
Table 17: PMC Status by Fiscal Year of Product Approval
Table 18: Reasons for Delayed PMC Status
Table 19: PMC Status by GRMPs Phase of PMC Notification
Table 20: Consistency in PMC Status Between FDA Databases and Interviews
Table 21: Timeliness of Sponsor PMC Submissions
Table 22: Timeliness of FDA Review of PMC Submissions
Table 23: Fulfilled PMC Impact on Label Changes
Table 24: Label Changes by PMC Study Category
Table 25: Label Changes by Study Subcategory
Table 26: Sponsor Perspectives on R&D Impact of Conducting PMCs and Potential Enforcement Options
Table 27: Summary of PMC Recommendations

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