FDA Opens PreCheck Pilot to Strengthen Domestic Pharmaceutical Manufacturing

On February 12, 2026, the U S Food and Drug Administration began accepting requests to participate in the FDA PreCheck pilot program. The agency frames PreCheck as a potential pathway to strengthen domestic pharmaceutical manufacturing by engaging industry and regulatory partners in an early testing phase. The current development invites manufacturers, suppliers, and related stakeholders to submit requests to join the program so the FDA can evaluate this approach in a real world setting. This article summarizes what changed, who may be affected, and what the next steps could be for participants and for regulators.

What changed?

The FDA has begun accepting requests to participate in the PreCheck pilot. This marks a concrete step in the agency’s effort to test new approaches for manufacturing oversight in the United States. The move expands opportunities for stakeholders to engage with the FDA as part of this pilot and to provide input on how the program could affect manufacturing and regulatory workflows. The focus remains on strengthening domestic pharmaceutical manufacturing through enhanced collaboration between regulators and industry partners.

Who is affected?

Participants may include manufacturers and suppliers engaged in domestic pharmaceutical production, along with related service providers and regulatory professionals. The article notes that requests to participate are now being accepted, which signals broad interest across the sector. Readers should consider how this development could influence quality systems, supply chain oversight, and regulatory communications in their organizations.

How can entities participate in the PreCheck pilot?

The FDA has opened a submission process for entities wishing to participate. Interested parties should refer to the official FDA release for details on eligibility, submission methods, and documentation requirements. The information link is provided at the end of this article. Stakeholders are advised to monitor FDA announcements for updates to the pilot scope and criteria. The official release is available at FDA press release.

What are the expected outcomes and regulatory implications?

As a pilot program PreCheck aims to test processes and gather data on how engagement with industry partners can affect manufacturing oversight. The article frames this as a step toward strengthening domestic manufacturing capacity. Readers should anticipate regulatory follow ups and potential updates to guidance based on pilot results. The dynamic underscores ongoing regulatory science work and the FDA’s efforts to balance speed with safety and quality in the domestic supply chain.