FDA Postmarketing Requirements and Commitments Status and Fulfillment Categories

1. Overview

The FDA maintains an internal database tracking the status of postmarketing requirements (PMRs) and commitments (PMCs) for human drugs and biologics. This information, updated quarterly, is made publicly available through the searchable Postmarket Requirements and Commitments database. The seven status categories help applicants, healthcare providers, and the public understand the progress of required or agreed-upon studies and clinical trials conducted after approval to gather additional safety, efficacy, or optimal use data. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories

2. Status Categories

The FDA uses the following seven categories to describe the current status of each PMR or PMC relative to its original schedule:

• Pending: The study has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criterion for delayed (i.e., the original projected date for initiation of patient accrual or initiation of animal dosing has not passed).

• Ongoing: The study is proceeding according to, or is ahead of, the original schedule. The FDA considers a study to be ongoing until a final study report is submitted to the FDA, as long as the activities are proceeding according to the original study schedule. If patient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, the study should be categorized as delayed.

• Delayed: The progression of the study is behind the original study schedule. Delays can occur in any phase of the study, including patient enrollment, analysis of study results, or submission of the final study report to the FDA. While the original study schedule — not a revised schedule — serves as the basis for defining a study as delayed, each phase of the study will be considered in its own right. If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.

• Terminated: The applicant ended the study before completion, and has not yet submitted a final study report to the FDA.

• Submitted: The applicant has concluded or terminated the study and has submitted a final study report to the FDA, but FDA has not yet notified the applicant in writing that the study commitment has been fulfilled or that the commitment has been released.

• Fulfilled: The applicant has submitted the final study report for the commitment, and upon review of the final study report, FDA is satisfied that the applicant has met the terms of the commitment.

• Released: FDA has informed the applicant that it has been released from its obligation to conduct the postmarketing study because the study is either no longer feasible or would no longer provide useful information.

Note: Fulfilled and released commitments are displayed on the website for no more than one year from the date the commitments are fulfilled or released. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories

3. Key Notes on Status Determination

Statuses are determined based on the original study schedule, not revised ones. Each phase (e.g., enrollment, analysis, reporting) is evaluated independently. The FDA verifies information from applicant annual status reports before posting to the public database. The categories apply uniformly to both PMRs (statutorily or regulatorily required) and PMCs (voluntary commitments). Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories

4. Searchable Database Resource

The public can search the Postmarket Requirements and Commitments database for detailed status information on specific products. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories

5. Contact for Assistance

For questions regarding postmarketing requirements and commitments, contact CDERImports@fda.hhs.gov or the relevant review division. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-status-and-fulfillment-categories