The US Food and Drug Administration (FDA) has reportedly selected the first companies for its PreCheck pilot program, which aims to expedite the approval process for new domestic drug manufacturing facilities.
According to a CNBC report citing FDA spokesperson Benjamin Nichols, Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin are among the first companies to participate in the program.
The PreCheck program will allow FDA officials to begin inspecting new manufacturing facilities while they are still under construction. The goal is to identify and correct potential issues early on. According to FDA estimates, this process could save companies up to 14 months during the approval phase.
The program is also seen as aligning with the Trump administration’s priority of increasing drug production within the United States. Among the selected companies are Eli Lilly—one of the world’s most valuable healthcare companies—as well as private biotechnology firms developing gene therapies.
The majority of the initial participants are reportedly planning to produce biologic drugs or genetic therapies. Such treatments require more complex manufacturing processes compared to traditional pill-form medications.
Companies wishing to participate in the FDA’s PreCheck program are reportedly required to establish a new manufacturing facility that will address a gap in market supply or increase access to treatments for unmet medical needs. Under the program, only drugs produced at that specific facility will be evaluated.
