Key Takeaways
- The U.S. Food and Drug Administration (FDA) recently launched two initiatives to help onshore U.S. pharmaceutical manufacturing: the FDA PreCheck Program to streamline review of pharmaceutical facilities and the previously announced Advanced Manufacturing Technologies (AMT) Designation Program, to encourage innovation and development of new manufacturing technology.
- Both programs aim to reduce reliance on foreign suppliers and bolster domestic capacity by offering enhanced communication with the agency and faster review times.
- The FDA will hold a public meeting on September 30, 2025, to discuss the onshoring of pharmaceutical manufacturing and to receive public comment.
The U.S. Food and Drug Administration (FDA) recently announced two initiatives to boost domestic pharmaceutical production. On August 7, 2025, the agency announced the voluntary FDA PreCheck Program to expedite review of new manufacturing sites.1 Earlier this year, the FDA also finalized guidance for its Advanced Manufacturing Technologies (AMT) Designation Program that creates a process to foster novel technology that will improve pharmaceutical manufacturing.2
The FDA PreCheck Program
The FDA PreCheck Program occurs in two phases. In the first, Facility Readiness Phase, manufacturers work with FDA during planning, design, construction, and pre-production of a facility. This information can then be compiled into a Master File for reference in a marketing application for a new drug, a biologic, a generic drug, or a biosimilar. In the second, Application Submission Phase of PreCheck, the facility and agency prepare a streamlined Chemistry, Manufacturing, and Controls application module for use in a marketing application.3
The AMT Designation Program
The AMT designation program facilitates the development and supply of advanced manufacturing technologies that can improve quality, reliability, and efficiency of critical medicines.4 Examples of such technologies include continuous manufacturing, 3D printing of drug products, modular manufacturing platforms, and advanced process analytical tools. A manufacturer can request AMT designation for its technology. The designation is granted based on the technology’s potential to increase manufacturing speed and the supply of critical medicines.5
The main benefit of AMT designation is enhanced communication with the FDA. An application that relies on a designated AMT will receive additional advice in early-stage meetings and written responses from the agency. The FDA will also designate an AMT lead for any application that relies on the AMT to ensure that questions about the technology are referred to appropriate experts within the agency.6
Both the PreCheck and AMT designation programs may incentivize product sponsors to contract with participating manufacturers. However, both parties to such a transaction should establish clear intellectual property rights before entering into an agreement in order to prevent later disputes about patent and trade secret ownership.
PreCheck and AMT designation are part of a broader shift in FDA policy to onshore U.S. pharmaceutical manufacturing. According to FDA Commissioner Marty Makary, “Our gradual overreliance on foreign drug manufacturing has created national security risks.”7 President Trump’s May 2025 Executive Order 14293 directed the FDA to “eliminate regulatory barriers to the domestic production of the medicines Americans need” within 180 days.8
FDA Schedules Public Meeting
The FDA will hold a public meeting on September 30, 2025, to discuss the onshoring of pharmaceutical manufacturing and to receive public comment. Participants can attend in-person in White Oak, Maryland, or by teleconference. Interested parties can also submit written comments before October 30, 2025.9
[1] U.S. Food and Drug Administration, FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing (Aug. 7, 2025), https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing.
[2] U.S. Food and Drug Administration, Advanced Manufacturing Technologies Designation Program - Guidance for Industry (Dec. 2024), at 4, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program.
[3] FDA PreCheck Program, note __ above, at id.
[4] See 21 U.S.C. § 356l
[5] Advanced Manufacturing, note __ above, at 4.
[6] Id. at 8.
[7] FDA PreCheck Program, note __ above, at id.
[8] Regulatory Relief to Promote Domestic Production of Critical Medicines, Exec. Order No. 14293, 90 Fed. Reg. 19615 (May 8, 2025).
[9] U.S. Food and Drug Administration, Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments, 90 Fed. Reg. 38475 (Aug. 8, 2025).
