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Postmarketing Requirements and Commitments: Status and Fulfillment Categories
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: The "fulfilled" and "released" commitments will be displayed on the Web site for not more than one year from the date the commitments are fulfilled or released.