The FDA officially launched its Manufacturing PreCheck Pilot Program on February 1, 2026, introducing a two-phase regulatory framework designed to accelerate construction and approval of new U.S. pharmaceutical manufacturing facilities. The initiative arrives as the contract development and manufacturing organization (CDMO) sector completes a record year of domestic investment, with $24.86 billion flowing to American facilities in 2025, representing 74% of the industry’s total disclosed capital expenditure.
The PreCheck program accepts applications through March 1, 2026, with the agency planning to select facilities for an initial cohort and begin conducting PreCheck activities in 2026. Selected participants will receive early FDA feedback during facility design and construction phases, potentially reducing late-stage compliance failures that have historically delayed product approvals.
Two-Phase Approach Decouples Facility Review from Product Applications
Phase 1, the Facility Readiness Phase, provides pre-operational engagement on facility design, construction qualification, and quality system readiness. Manufacturers submit facility-specific information through a Type V Drug Master File covering site operations, pharmaceutical quality systems, and quality management maturity practices.
Phase 2, the Application Submission Phase, offers pre-submission meetings dedicated to resolving manufacturing-related issues and enables earlier assessment of Chemistry, Manufacturing, and Controls (CMC) elements within application review cycles.
FDA Commissioner Marty Makary emphasized the program’s strategic importance: “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”
Eligibility Requirements Target New Domestic Capacity
The pilot program applies exclusively to new U.S. manufacturing facilities, not existing sites or facility expansions. Eligible participants must have broken ground or commit to breaking ground by May 1, 2026, and demonstrate capacity to produce sufficient quantities for intended market needs.
Participants must commit to submitting new drug applications, abbreviated new drug applications, biologics license applications, or Type II Drug Master Files during program participation. Companies must also commit to actively manufacturing products at the facility for at least three years following FDA approval of products made during the pilot.
The agency will prioritize facilities that:
- Manufacture finished dosage forms or drug products using U.S.-sourced active pharmaceutical ingredients
- Develop products addressing drug shortages, critical medicines, or supply chain vulnerabilities
- Employ novel approaches including modular construction, advanced automation, or digital integration
- Can achieve operational status on expedited timelines
Questions Remain on Program Scope and Industry Impact
Several industry stakeholders expressed concerns about program limitations during the September 2025 public meeting that informed PreCheck’s design. The FDA declined to extend the pilot to facility expansions, technology transfers, or modernization of existing sites. Restrictions that may limit the program’s effectiveness in addressing immediate supply chain vulnerabilities.
Legal analyses note the program cannot substitute for product-linked pre-approval inspections, as approval decisions ultimately depend on application-specific data and inspection results demonstrating real-time manufacturing operations meet current Good Manufacturing Practice requirements.
The application submission form requires extensive commitments including compliance representations, agreement to pre-operational engagement, willingness to share information via Type V Drug Master Files, and three-year manufacturing pledges. The FDA has not clarified consequences for participants unable to meet these commitments.
Application Timeline and Selection Process
Companies must submit PreCheck proposals by March 1, 2026. The FDA will notify finalists by April 1, requesting additional documentation due May 1. Final cohort selection occurs by June 30, 2026, with PreCheck activities beginning later in 2026.
Interested applicants should submit proposals through the FDA’s dedicated submission portal. The agency will evaluate facilities based on overall alignment with national priorities across multiple selection criteria, though it has not published a scoring rubric or explained factor weighting.
The PreCheck program reflects broader administration efforts to reduce pharmaceutical import dependence, with more than 50% of pharmaceuticals distributed in the U.S. currently manufactured overseas and only 11% of active pharmaceutical ingredient manufacturers operating domestically.
