(571 Kb) Access

: The FDA generally reports a steady decrease in the total number of open backlog files as studies are completed or closed.

: 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)

: 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. : The FDA generally reports a steady decrease

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: This report is part of a series provided

: Studies are categorized into "Pending" (not yet started), "Ongoing" (study underway), "Delayed" (behind the original schedule), or "Terminated/Released" (no longer required).

The search result you referenced is likely the , a PDF document exactly 571 KB in size, published by the U.S. Food and Drug Administration (FDA) .

: A primary goal of the report is to demonstrate that the FDA is actively pushing for the completion of these studies to ensure long-term drug safety and efficacy. Other Possible Documents (571 KB)