Objective:
To support domestic pharmaceutical manufacturing and strengthen the US drug supply chain.
Approach:
- Pilot Program Launch: The PreCheck Pilot Program was launched on February 1, 2026, following a 2025 executive order on domestic drug manufacturing.
- Selection Criteria: Companies had to propose a new US manufacturing facility addressing market supply needs or improving patient access to therapies for unmet medical needs.
- Phased Process: Participants will undergo a two-phase process: Facility Readiness and Application Submission, receiving early technical guidance and pre-submission meetings.
Key Findings:
- Sevencompaniesselected:AmnealPharmaceutical(small-moleculesterileliquidproducts),Cellares(cell-basedgenetherapyproducts),EliLillyandCompany(activepharmaceuticalingredientmanufacturing),FujifilmBiotechnologies(commercial-scalecellculturebiomanufacturing),KriyaTherapeutics(AAV-basedgenetherapyproducts),KyowaKirin(biotechnologydrugsubstance),andRegeneronPharmaceuticals(biotechnologydrugsubstance,sterileinjectables,andnovelproteintherapeutics).TheFDAreceivedover80requeststoparticipateintheprogram.
Interpretation:
The program aims to reduce uncertainty around facility readiness and application review by providing earlier technical feedback.
Limitations:
- Thepilotdoesnotapprovefacilitiesorproductsinadvance.Itisintendedtoidentifymanufacturingissuesbeforetheydelaydrugorbiologicsapplications.
Conclusion:
The initiative is designed to enhance the US drug supply chain by supporting the establishment of new manufacturing sites.
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