FDA Launches “PreCheck” Program to Support U.S. Pharmaceutical Manufacturing: What Industry Stakeholders Should Know

On August 7, 2025, the U.S. Food and Drug Administration (FDA) announced FDA PreCheck, a new two-phase framework aimed at bolstering the domestic pharmaceutical supply chain by streamlining the regulatory process for U.S.-based drug manufacturing facilities. Notably, the announcement also included information regarding an upcoming public meeting about the PreCheck framework and opportunity to comment and engage with the FDA on the program itself.

Supply Chain Vulnerabilities and Policy Response

This move comes at a time when the majority of pharmaceuticals distributed in the United States — and the active pharmaceutical ingredients (APIs) they contain — are sourced from overseas.  According to the FDA’s Notice of the public meeting for PreCheck, as of June 2025:

• 53% of branded drugs and 69% of generic drugs distributed in the U.S. have at least one foreign manufacturer.
• Only 9% of Type II Drug Master File (DMF) holders for APIs are based in the U.S., compared to 22% in China and 44% in India.

The FDA has identified the globalization of pharmaceutical manufacturing as a growing risk to public health and national security. On May 5, 2025, the President issued Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to eliminate duplicative or unnecessary regulatory burdens and streamline the establishment of U.S.-based pharmaceutical manufacturing operations.

Overview of FDA PreCheck Proposal

FDA PreCheck is a direct response to Executive Order 14293, as the initiative is intended to provide greater regulatory clarity and predictability for companies looking to invest in domestic drug manufacturing capabilities. Based on the registration criteria for the upcoming public meeting, it appears that FDA PreCheck will focus on facilities that intend to produce:

• APIs and drug products that address current or potential drug shortages;
• APIs and drug products on the FDA’s Essential Medicines List; and
• Drug products addressing known supply chain vulnerabilities, such as sterile injectables and large volume parenterals (LVPs).

The PreCheck initiative consists of two phases:

• Facility Readiness Phase: This phase encourages early and frequent engagement with the FDA during site design and construction. Sponsors are invited to submit facility-specific information via a Type V DMF, detailing layout, operations, quality systems, and Quality Management Maturity (QMM) practices. Early engagement helps identify and address potential compliance issues before they become obstacles.
• Application Submission Phase: This phase focuses on accelerating the development of the Chemistry, Manufacturing, and Controls (CMC) portion of applications. Through pre-submission meetings and early FDA feedback, companies can resolve regulatory questions proactively, reducing the risk of delays during the formal review process.

Public Meeting and Stakeholder Feedback

To foster dialogue with stakeholders, the FDA will host a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” on September 30, 2025. Interested parties may attend in person or virtually by registering here. The FDA is particularly interested in stakeholder comments on:

• Significant regulatory hurdles to new domestic manufacturing facilities;
• Most useful elements of the PreCheck framework;
• Suggestions for additional implementation considerations; and
• Willingness to share facility-specific data (e.g., quality systems, Current Good Manufacturing Practice (cGMP) compliance) outside the drug application context.

In addition to the above, the FDA is also welcoming broader suggestions to strengthen U.S. pharmaceutical manufacturing under its existing authorities.  Interested parties have until October 30, 2025, to submit electronic or written comments on the public meeting.

Implications for Industry

FDA PreCheck presents a novel opportunity for drug and biologic manufacturers seeking to establish U.S.-based facilities aligned with national health security priorities. Companies involved in the production of critical APIs, sterile products, or shortage-prone drug products should assess whether participation in the PreCheck program can offer regulatory and operational advantages.  Early engagement with the FDA, including preparation of a Type V DMF and participation in pre-application meetings, may offer strategic benefits in navigating CMC requirements and expediting approval time lines.

Next Steps

Navigating the evolving regulatory landscape can be complex, especially as the FDA introduces new programs like PreCheck. As discussed in a previous blog post, it is important to remain vigilant about FDA regulatory obligations and strategic considerations tied to ongoing onshoring initiatives, including Prior Approval Supplement (PAS) Requirements, Pre-Approval Inspection Protocols (PAIPs), and enhanced Foreign Manufacturing Surveillance (FMS).

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.