The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities.
The pilot is designed to increase regulatory predictability and support earlier engagement with manufacturers during facility development before a specific drug application is submitted, according to a Feb. 1 agency news release.
The FDA plans to select an initial cohort of pharmaceutical manufacturing facilities and begin PreCheck activities later this year. Facilities will be evaluated based on factors such as the products to be manufactured, development timelines and alignment with U.S. market needs.
The PreCheck pilot is intended to streamline aspects of manufacturing facility assessments and support domestic pharmaceutical production, the agency said.
