: 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.
: 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 (571 KB)
: Studies are categorized into "Pending" (not yet started), "Ongoing" (study underway), "Delayed" (behind the original schedule), or "Terminated/Released" (no longer required). : These reports typically track the number of