The USA Food and Drug Administration (FDA) has launched a new pilot initiative aimed at strengthening domestic drug manufacturing and reinforcing the country’s pharmaceutical supply chain. The program, named PreCheck, is designed to make it easier and more predictable for companies to construct and operate pharmaceutical manufacturing facilities in the USA.

Under the PreCheck framework, the FDA will begin accepting applications from new facilities that align with national priorities, including the production of critical medications and the development of innovative manufacturing processes. Selected facilities will be able to engage with the agency earlier and more frequently during the design, construction and pre-production phases, helping to identify and resolve technical issues before formal product applications are submitted.

The PreCheck program has a two-phase structure. In the first phase, known as the Facility Readiness Phase, participating manufacturers receive early technical guidance and support from the FDA on facility design and quality control strategies. The second phase, the Application Submission Phase, focuses on facilitating pre-application meetings and early regulatory feedback on chemistry, manufacturing and controls information, which can streamline later reviews.

FDA Commissioner Marty Makary said the initiative reflects a strategic effort to make domestic drug manufacturing more resilient and competitive. By boosting regulatory predictability and encouraging facility development within the USA, the program seeks to reduce reliance on overseas production and enhance supply chain security.

The launch of PreCheck supports broader federal efforts aimed at promoting domestic pharmaceutical production and supply chain resilience. In addition to the PreCheck program, the FDA has introduced other measures, such as priority review pathways for drugs that address critical health needs or national security concerns, further reinforcing incentives for companies to manufacture in the USA.

Industry feedback helped shape the design of the PreCheck program, with stakeholders expressing strong support for more predictable regulatory engagement during early stages of facility development. The FDA plans to begin PreCheck activities in 2026 with an initial cohort of participating manufacturing sites.