The U.S. Food and Drug Administration began accepting applications today, February 1, 2026, for its new FDA PreCheck pilot program, a move designed to revitalize domestic pharmaceutical manufacturing. The initiative aims to cut red tape, encourage investment in U.S. facilities, and ultimately strengthen the nation’s drug supply chain.

Bringing Manufacturing Back Home

The FDA PreCheck program is a key part of a broader effort to onshore pharmaceutical production after decades of reliance on overseas manufacturers.

  • The program offers early engagement with the FDA during facility development.
  • It streamlines documentation processes for manufacturers.
  • Priority will be given to facilities producing critical medications.
  • The FDA will select an initial cohort of facilities in 2026.

“After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”

What exactly does this mean for patients? Increased domestic manufacturing could lead to a more stable supply of essential medicines, reducing the risk of shortages and ensuring Americans have access to the drugs they need.

How FDA PreCheck Works

The FDA developed the PreCheck program based on feedback received during the “Onshoring Manufacturing of Drugs and Biological Products” public meeting held on September 30, 2025, and through public comments submitted via the Federal Register. Industry representatives voiced strong support for early collaboration with the FDA and simplified documentation.

The program unfolds in two phases. Phase 1, the Facility Readiness Phase, allows manufacturers to receive technical guidance from the FDA *before* a facility is fully operational. This includes pre-operational reviews and the use of a facility-specific Drug Master File to expedite the evaluation of facility details during the drug application process. Phase 2, the Application Submission Phase, builds on this foundation with pre-submission meetings and inspections to resolve issues and accelerate the assessment of manufacturing information within a drug application.

Selection Criteria and Priorities

The FDA will select facilities based on several factors, including the types of products to be manufactured, the stage of facility development, the timeline for producing drugs for the U.S. market, and the level of innovation incorporated into the facility’s design. Facilities focused on producing critical medications for the U.S. market will receive additional consideration.

The FDA, an agency within the U.S. Department of Health and Human Services, is dedicated to protecting public health by ensuring the safety, effectiveness, and security of drugs, vaccines, medical devices, and the nation’s food supply.

Interested manufacturers can find more information, including eligibility requirements and selection criteria, on the FDA PreCheck web page.