FDA Names PreCheck Participants - Summary - MDSpire

FDA Names PreCheck Participants

Seven companies will participate in a two-phase program that provides early FDA technical guidance during development of new US pharmaceutical manufacturing facilities.

  • By

  • Kathryn Wighton

  • June 30, 2026

  • 3 min

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Objective:

To support the development of new US pharmaceutical manufacturing facilities through earlier FDA engagement.

Approach:
  • Pilot Program Launch: The FDA PreCheck Pilot Program was launched on February 1, 2026, following Executive Order 14293.
  • Selection Process: The FDA received over 80 requests and selected seven companies based on standardized evaluation criteria.
  • Company Engagement: Participants will engage with the FDA in a two-phase model focusing on facility readiness and application submission.
Key Findings:
  • Seven companies selected: Amneal Pharmaceuticals, Cellares Corp., Eli Lilly and Company, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin, Inc., and Regeneron Pharmaceuticals, Inc.
  • Proposed facilities will produce various drug products including sterile injectables and gene therapies.
  • The program aims to reduce uncertainty related to manufacturing readiness.
Interpretation:

The PreCheck Pilot Program is designed to facilitate earlier FDA engagement with pharmaceutical manufacturers.

Limitations:
  • The program's effectiveness and impact on future manufacturing processes remain to be evaluated.
Conclusion:

The FDA will continue to assess the implementation of the pilot program for future development.

Sources:

Original Source(s)

FDA Names PreCheck Participants

  • by Kathryn Wighton

  • June 30, 2026

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