: To provide Congress with transparent data on the FDA's progress in managing the "backlog" of postmarketing studies that drug companies are required or have committed to conduct after a drug is approved.
: These reports typically track the number of open PMRs/PMCs, the percentage that are on schedule versus delayed, and the FDA's efficiency in reviewing the final study reports submitted by manufacturers. (571 KB)
This report is part of a series provided to Congress regarding the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs). Below is a summary based on the standard contents of these annual FDA backlog reports: : To provide Congress with transparent data on
: The "backlog" specifically refers to older requirements and commitments that were established before certain regulatory modernizations (like those under the Food and Drug Administration Amendments Act of 2007). Common Findings in Recent Backlog Reports Below is a summary based on the standard