FDA's Precheck Pilot Program

FDA Launches “PreCheck” Pilot Program to Accelerate U.S. Pharmaceutical Manufacturing

The U.S. Food and Drug Administration has launched a new pilot initiative aimed at strengthening domestic pharmaceutical manufacturing and improving regulatory predictability for companies building drug production facilities in the United States.

The program, called FDA PreCheck, is designed to allow pharmaceutical manufacturers to engage with FDA earlier in the facility development process, enabling the agency to evaluate manufacturing readiness before a specific drug application is submitted. FDA is now accepting requests from companies interested in participating in the pilot program, with the first cohort of facilities expected to begin activities in 2026.

Program Overview

The FDA PreCheck program is intended to support onshoring pharmaceutical manufacturing by creating a more predictable regulatory pathway for companies developing new manufacturing facilities in the United States.

Under the program, FDA will select an initial group of manufacturers whose facilities align with national priorities such as production of critical or essential medicines, facility development timelines, innovation in manufacturing technology, and ability to supply drugs to the U.S. market.

The program is part of broader federal efforts to reduce reliance on overseas pharmaceutical manufacturing and strengthen supply chain resilience.

Two-Phase Regulatory Engagement Model

FDA PreCheck introduces a two-phase regulatory engagement framework.

Phase 1: Facility Readiness Phase

During the first phase, FDA will provide early technical engagement with manufacturers while the facility is still under development. Activities may include pre-operational facility reviews, technical discussions with FDA experts, and submission of a facility-specific Drug Master File (DMF).

The DMF allows FDA reviewers to evaluate facility design, processes, and manufacturing systems before the facility becomes operational.

Phase 2: Application Submission Phase

Once a company prepares to submit a drug application, the second phase builds upon earlier engagement through pre-submission meetings with FDA facility inspections and resolution of manufacturing-related issues prior to review.

This structure is intended to streamline the evaluation of manufacturing information within drug applications and reduce delays during regulatory review.

Program Shaped by Industry Feedback

FDA developed the PreCheck program with input from industry stakeholders during the September 2025 public meeting on onshoring pharmaceutical manufacturing, as well as comments submitted through the Federal Register.

Industry participants emphasized the importance of earlier engagement with FDA during facility development, clearer documentation expectations, and streamlined regulatory review processes for manufacturing facilities.

The PreCheck framework reflects these priorities by allowing companies to address manufacturing readiness issues well before submitting a drug application.

Why This Matters

Pharmaceutical manufacturing capacity in the United States has declined significantly over the past several decades as production shifted overseas. Recent supply disruptions, including shortages of critical medications, have highlighted the risks associated with globalized supply chains.

Programs like FDA PreCheck are intended to encourage companies to build advanced pharmaceutical manufacturing facilities in the U.S. by reducing regulatory uncertainty and improving coordination between manufacturers and regulators.

For companies investing in domestic production capacity, earlier regulatory engagement may help reduce delays associated with facility inspections and manufacturing readiness reviews.

MDP Perspective

The FDA PreCheck pilot program represents a meaningful shift toward earlier regulatory engagement in pharmaceutical manufacturing facility development. By allowing companies to work with FDA during facility design and construction, the agency is attempting to address one of the most common causes of regulatory delay – manufacturing readiness issues identified late in the review process.

If implemented effectively, this model could improve regulatory predictability and accelerate the availability of drugs manufactured in the United States. It may also signal a broader trend toward more collaborative regulatory frameworks that emphasize early engagement rather than post-submission correction of manufacturing deficiencies.

For pharmaceutical manufacturers considering new U.S. production facilities, participation in the PreCheck program may provide an opportunity to reduce regulatory risk while aligning facility development with FDA expectations.