August 7, 2025 – The U.S. Food and Drug Administration (FDA) has announced the launch of FDA PreCheck, a new initiative designed to bolster the domestic pharmaceutical supply chain by streamlining regulatory oversight and supporting the construction of new drug manufacturing facilities across the United States.

Currently, more than half of pharmaceuticals distributed in the U.S. are produced overseas, with only 11% of FDA-approved active pharmaceutical ingredient (API) manufacturers based in the U.S. This heavy reliance on foreign supply has raised concerns about national security and resilience.

“America’s overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA PreCheck initiative is one of many steps the agency is taking to help reverse this trend and strengthen the domestic drug supply.”

The program stems from Executive Order 14293, Regulatory Relief to Promote Domestic Production of Critical Medicines, which directs FDA to eliminate unnecessary requirements and increase regulatory predictability for domestic manufacturing.

How FDA PreCheck Works 

FDA PreCheck introduces a two-phase approach for manufacturers:

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  1. Facility Readiness Phase – Offers more frequent FDA engagement at key stages such as facility design, construction, and pre-production. Companies are encouraged to submit comprehensive facility-specific data via a Type V Drug Master File (DMF), including site layout, quality systems, and maturity practices. This DMF can then be referenced in drug applications.
  2. Application Submission Phase – Streamlines development of the Chemistry, Manufacturing, and Controls (CMC) section of applications through pre-application meetings and early FDA feedback.

Driving Business Efficiency

For pharmaceutical and biotechnology clients, the collaboration offers the potential for streamlined workflows and greater operational efficiency. By integrating IQVIA data into Veeva Network and Nitro—and vice versa—companies can sharpen market analysis, optimize sales strategies, and strengthen commercial execution. The resulting efficiencies may reduce costs, accelerate market access, and improve return on investment.

Upcoming Public Meeting

To engage stakeholders, the FDA will host a public meeting, “Onshoring Manufacturing of Drugs and Biological Products,” on September 30, 2025, from 9:00 AM to 4:00 PM at the FDA White Oak Campus in Silver Spring, Maryland. Virtual participation will also be available. The session will include a presentation of the draft PreCheck framework, panel discussions on its potential impact, and exploration of additional strategies to overcome onshoring challenges.

Source: FDA Press Release