Postmarketing 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 postmarketing requirements and commitments. The annual notice is intended to summarize the information in the postmarketing 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 postmarketing requirements and commitments in the Agency database. The information in the Federal Register is updated annually, while the numbers on the Web site are updated quarterly.

Annual Notices

• FY2011  (PDF - 112KB )
• FY2010  (PDF - 201KB ) -- Correction Notice  (PDF - 181KB )
• FY2009  (PDF - 73KB )
• FY2008  (PDF - 65KB )
• FY2007  (PDF - 57KB )
• FY2006 (PDF - 53KB)
• FY2005 (PDF - 53KB)
• FY2004 (PDF - 59KB)
• FY2003 (PDF - 42KB)
• FY2002 (PDF - 38KB)

 

Reports to Congress

Food and Drug Administration Modernization Act of 1997 (FDAMA)

• "Report to Congress: Reports on Postmarketing Studies [FDAMA 130]"
   

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Section 921 of FDAAA added a requirement for FDA to “on an annual basis, review the entire backlog of postmarketing safety commitments to determine which commitments require revision or should be eliminated, report to the Congress on these determinations, and assign start dates and estimated completion dates for such commitments.” For the purposes of this task, the PMR/PMC backlog was defined as all open PMRs and PMCs (not fulfilled or released) as of the date of FDAAA enactment (September 27, 2007).

• Third annual backlog report to Congress: 2012 (PDF - 56KB) 
• Second annual backlog report to Congress: 2011 (PDF - 61KB)
• First annual backlog report to Congress: 2010 (PDF - 52KB)

FDA contracted with Booz Allen Hamilton (BAH) in conducting the first and second annual backlog reviews of CDER PMRs/PMCs. Their reports are listed below.

• First annual report (PDF - 422KB) 
• Second annual report (PDF - 2MB) 

 

Other Reports

• Final Report on the Independent Evaluation of FDA's Prescription Drug User Fee Act III – Evaluations & Initiatives

As part of ongoing initiatives to improve the process for developing and tracking postmarket requirements and commitments, the FDA contracted with 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, FDA developed, revised, and implemented procedures to further improve our processes for tracking postmarketing requirements and commitments.

The following two Manuals of Policies and Procedures (MaPPs) were published in 2009:

• Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (MAPP 6010.9) was posted on March 9, 2009. 

• Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments (MaPP 6010.2) was posted on July 28, 2009.