The FDA has announced a new program called FDA PreCheck, meant to increase “regulatory predictability and [facilitate] the construction of manufacturing sites in the U.S.”
The program is meant to bolster America’s domestic drug supply. As of now, “more than half of pharmaceuticals distributed in the U.S. are manufactured overseas,” and the U.S. is reliant on overseas sources for “active pharmaceutical ingredients (APIs).”
FDA PreCheck was developed in response to an executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines.” The order “directs FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability.”
The PreCheck program introduces a two-phase approach. The first phase is called the “Facility Readiness Phase,” which “provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide comprehensive facility-specific information through a Type V Drug Master File (DMF).” The next phase is the “Application Submission Phase,” which “centers on streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback.”
