What are the open status categories for FDA postmarketing requirements and commitments?

Open Status Categories：

1. Pending: The study/clinical trial 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).

2. Ongoing: The study/clinical trial is proceeding according to, or is ahead of, the original schedule. The FDA considers a study/clinical trial to be ongoing until a final report is submitted to the FDA, as long as the activities are proceeding according to the original 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/clinical trial should be categorized as delayed.

3. Delayed: The progression of the study/clinical trial is behind the original schedule. Delays can occur in any phase of the study/clinical trial, including patient enrollment, analysis of results, or submission of the final report to the FDA. While the original schedule—not a revised schedule—serves as the basis for defining a study/clinical trial as delayed, each phase of the study/clinical trial 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.

4. Terminated: The applicant ended the study/clinical trial before completion and has not yet submitted a final report to the FDA.

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