For decades, pharmaceutical manufacturing steadily migrated overseas, leaving the U.S. dependent on fragile global supply chains. With the launch of the FDA PreCheck pilot program, the agency is offering manufacturers something long requested: regulatory predictability before product submission. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by facilitating the construction of U.S.-based manufacturing facilities and streamlining regulatory assessments well in advance of a specific drug application.
FDA PreCheck is a voluntary, two-phase pilot program that supports manufacturers developing new U.S. pharmaceutical facilities for drugs and biologics, including both finished dosage forms (FDF) and active pharmaceutical ingredients (API). The program begins accepting participants now, with PreCheck activities starting in 2026.
Phase 1: Facility Readiness Phase focuses on early FDA engagement before a facility becomes operational. Manufacturers receive technical feedback through pre-operational reviews and can submit a facility-specific Drug Master File (DMF), allowing FDA to assess facility elements independently of a product application.
Phase 2: Application Submission Phase builds on this foundation, enabling pre-submission meetings and inspections that leverage earlier reviews to resolve issues faster and streamline manufacturing assessments within drug applications.
Key benefits include early FDA feedback, enhanced communication throughout facility development, and continuity between early reviews and later inspections.
Onshoring drug manufacturing has long been linked to higher resilience, but also higher costs. FDA PreCheck helps address this to some extent. By reducing regulatory uncertainty, shortening timelines, and minimizing late-stage inspection surprises, PreCheck lowers development risk and capital inefficiencies. These efficiencies can translate into more predictable production, fewer supply disruptions, and ultimately improved access to essential medicines. For critical drugs, explicitly prioritized under PreCheck, domestic manufacturing supported by streamlined regulatory pathways may help stabilize pricing and reduce shortages that disproportionately affect U.S. patients.
FDA PreCheck is not emerging in isolation. It shares similarities with prior FDA efforts:
- Early engagement, consistent with programs like CMC-focused pre-IND and pre-NDA meetings.
- Risk-based oversight, aligning with FDA’s broader shift toward modern quality and inspection paradigms.
- Supply chain resilience goals, echoing initiatives launched during and after COVID-19 to prevent shortages.
What Makes PreCheck Different are:
- Facility-first review, decoupled from a specific product submission.
- Formalized pre-operational assessments, rather than informal or ad hoc interactions.
- Explicit alignment with national onshoring policy, including Executive Order 14293 on domestic production of critical medicines.
FDA PreCheck represents a strategic recalibration of how the agency supports pharmaceutical manufacturing in the U.S. By engaging earlier, reviewing smarter, and prioritizing domestic capacity, the FDA is lowering barriers without lowering standards. If successful, PreCheck could become a cornerstone of a more resilient, accessible, and affordable U.S. drug supply, built not offshore, but at home.
