Who Qualifies for the New FDA PreCheck Pilot Program? February 16, 2026 By Kalie E. Richardson —

https://www.thefdalawblog.com/2026/02/who-qualifies-for-the-new-fda-precheck-pilot-program/?utm_source=rss&utm_medium=rss&utm_campaign=who-qualifies-for-the-new-fda-precheck-pilot-program FDA is now accepting submissions to its PreCheck Pilot Program, which is the Agency’s latest initiative to increase domestic production of pharmaceuticals. The two-phase structure of the Program and its benefits to industry, which we previously detailed in connection with the Onshoring Manufacturing of Drugs and Biological Products Public Meeting, have not significantly changed. However, FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.