Drugs
Postmarket Requirements and Commitments: Reports
Annual Report in the Federal Register
The 1997 Modernization Act required FDA to publish annually a notice in the Federal Register containing information on the performance of postmarket requirements and commitments. The annual notice is intended to summarize the information in the postmarket requirements and commitments database. Note that the numbers that publish in the annual Federal Register notice cannot be compared to the numbers resulting from searches of the database on the Web site. The annual Federal Register notice incorporates totals for all postmarket requirements and commitments in the Agency database. The information in the Federal Register is updated annually, whereas the numbers on the Web site is updated quarterly.
Annual Notices
- FY2007 (PDF - 57KB)
- FY2006 (PDF - 53KB)
- FY2005 (PDF - 53KB)
- FY2004 (PDF - 59KB)
- FY2003 (PDF - 42KB)
- FY2002 (PDF - 38KB)
- Reports
Final Report on the Postmarketing Requirement/Postmarketing Commitment Backlog Review (posted 9/3/2009)
As part of ongoing initiatives to improve the process for developing and tracking postmarket requirements and commitments, the FDA commissioned Booz Allen Hamilton (BAH) in 2006 to conduct an independent analysis of the Agency's postmarket processes and procedures. The final report, describing the results of their analysis and recommendations for improvement, was released in March 2008. Final Report: Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives (PDF - 369 KB)
Based on the BAH report, and on the new authority to require certain postmarket studies provided under the 2007 (FDAAA), the FDA is developing and implementing procedures to further improve our processes for tracking postmarket requirements and commitments.
The FDA also published, on March 9, 2009: Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (MAPP 6010.9).