Clinical Report: FDA Selects Seven Companies for Drug Manufacturing Pilot

Overview

The FDA has initiated the PreCheck Pilot Program, selecting seven companies to enhance domestic pharmaceutical manufacturing. This program aims to provide early technical feedback to support the development of new manufacturing sites.

Background

The PreCheck Pilot Program is a response to the need for improved domestic drug manufacturing, following an executive order. The initiative addresses challenges related to drug shortages and engages with manufacturers early in the process to mitigate potential manufacturing issues.

Data Highlights

The selected companies include:

• Amneal Pharmaceutical - Long Island, NY (small-molecule sterile liquid products)
• Cellares - Bridgewater, NJ (cell-based gene therapy products)
• Eli Lilly - Lebanon, IN (active pharmaceutical ingredient manufacturing)
• Fujifilm Biotechnologies - Holly Springs, NC (commercial-scale cell culture biomanufacturing)
• Kriya Therapeutics - Durham, NC (AAV-based gene therapy products)
• Kyowa Kirin - Sanford, NC (biotechnology drug substance)
• Regeneron Pharmaceuticals - Saratoga Springs, NY (biotechnology drug substance, sterile injectables, novel protein therapeutics)

Key Findings

• The FDA received over 80 requests to participate in the PreCheck Pilot Program.
• Eligible companies must propose a new U.S. manufacturing facility addressing market supply needs.
• The program consists of two phases: Facility Readiness and Application Submission.
• Participants will receive early technical guidance and facility-focused pre-submission meetings.
• The pilot does not approve facilities or products in advance.

Clinical Implications

The PreCheck Pilot Program may lead to more efficient drug manufacturing processes, potentially reducing the time to market for new therapies. By addressing manufacturing issues early, the program aims to enhance the reliability of the drug supply chain.

Conclusion

The FDA's PreCheck Pilot Program represents an effort to support domestic pharmaceutical manufacturing.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
2. conexiant, Conexiant, 2026 -- FDA Names PreCheck Participants
3. FDA, FDA, 2024 -- Drug Shortages Report to Congress | Calendar Year 2024
4. asco ai in oncology — FDA Explores AI to Accelerate Early-Phase Clinical Trials in Pilot Program
5. The ASCO Post — FDA Launches Pilot Program to Help Reduce Risks Associated With Using Laboratory Developed Tests to Identify Cancer Biomarkers
6. United States Department of Health and Human Services — WTAS: FDA Announces Major Steps to Implement Real-Time Clinical Trials
7. FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing | FDA
8. Drug Shortages Report to Congress | Calendar Year 2024
9. Clinical Guidance - ASCO