PreCheck Pilot Program Submission

The window to submit requests to participate in the PreCheck Pilot Program initial cohort is now closed. We thank all the organizations that submitted requests and appreciate the strong interest in advancing domestic pharmaceutical manufacturing. FDA will review submissions in accordance with the published eligibility and selection criteria. Companies selected as finalists will be notified directly via email by April 1, 2026, and final pilot program participant selections are expected by June 30, 2026.

Due to the anticipated volume of submissions, FDA is unable to provide individual status updates during the evaluation period. All organizations who submitted requests will be notified once final decisions have been made. Information regarding future iterations or expansion of the PreCheck Program will be posted on this webpage as it becomes available.

Thank you.