Meeting | Mixed
Event Title
FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products
September 30, 2025
- Date:
- September 30, 2025
- Time:
- 9:00 a.m. - 4:00 p.m. ET
- Location:
-
Event LocationWhite Oak Campus: The Great Room
Conference Center
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States
This public meeting will also have an option for virtual attendance.
Background
A resilient supply chain for medical products, and specifically, pharmaceuticals and biological products, is critical for the safety and security of the United States. The globalization of pharmaceutical production over the past several decades complicates these challenges.
Until the 2000’s, pharmaceutical manufacturing was largely a domestic enterprise. In the last several decades, however, such manufacturing has increasingly moved offshore. Today, more than half of the pharmaceuticals distributed in the U.S. are manufactured overseas. As of 2025, approximately 53% of brand drug products and 69% of generic drug products are manufactured outside of the United States. As of 2025, only 9% of API manufacturers are in the U .S., compared to 22% in China and 44% in India.
To help bolster pharmaceutical supply chain resiliency in the U.S., on May 5, 2025, the President issued Executive Order (EO) 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines.” EO 14293 sets forth a policy intended to streamline the regulation of manufacturing pharmaceutical products to facilitate the restoration of a robust domestic pharmaceutical manufacturing base. EO 14293 directs FDA to review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and take steps to “eliminate any duplicative or unnecessary requirements…; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing.”
In response to EO 14293, FDA has developed a proposal, FDA PreCheck to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain. Specifically, the proposal consists of a two-phase approach: (1) Facility Readiness Phase, and (2) Application Submission Phase. In Phase 1, the Facility Readiness Phase, selected manufacturers can engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1, and engage through pre-submission meetings to resolve issues and expedite assessments of quality information in a drug application and inspections.
Public Meeting Information
The public meeting will be available in-person or virtually. The in-person meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference Center, Silver Spring, MD 20993. Entry for meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. Participants must be REAL ID compliant to access federal facilities. For additional information regarding REAL ID, refer to https://www.dhs.gov/real-id/real-id-faqs. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information. The virtual meeting will be available via a link that registrants will receive after completing registration (see Registration section below for more details).
To facilitate discussion on enhancing domestic pharmaceutical manufacturing, FDA has developed a proposal to facilitate the establishment of new pharmaceutical manufacturing facilities in the U.S. to strengthen the domestic pharmaceutical supply chain. FDA is seeking input on the proposal, as well as other ideas to incentivize or strengthen pharmaceutical manufacturing in the U.S. In all cases, FDA encourages stakeholders to provide the specific rationale and basis for their comments, including any available supporting data and information.
On the proposal, FDA is seeking specific input on the following:
- What do you consider the most significant regulatory hurdle in establishing a new domestic pharmaceutical manufacturing facility?
- Which specific element(s) of the FDA PreCheck proposal are most likely to help the establishment of new US manufacturing facilities?
- Are there additional elements or implementation considerations that should be considered in the FDA PreCheck proposal?
- Would your company be willing to provide information about manufacturing facilities relevant to FDA oversight (e.g., facility design, quality systems, CGMP compliance, processes and controls, qualification or validation data) in advance of, or separate from, an application submission? What concerns might you have about sharing this information?
FDA is also interested in other ideas participants have to help incentivize or strengthen pharmaceutical and biological product manufacturing in the U.S.
Submitting Electronic or Written Comments
Submit electronic comments through the Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted publicly to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. Comments with confidential information should be submitted only as a written or paper submission.
Written/Paper Submissions
Send written comments by mail, hand delivery, or courier to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
FDA will post all comments, as well as any attachments, at https://www.regulations.gov or make them publicly viewable at the Dockets Management Staff office between 9 a.m. and 4 p.m. ET, Monday through Friday, 240-402-7500, unless the information is submitted, marked and identified as confidential as detailed in the instructions.
Instructions
All submissions must include the Docket No. FDA-2025-N-2489 for “Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments.” Comments received by the due date will be placed in the docket and, except for those submitted as "Confidential Submissions," be made public.
Confidential Submissions
To submit a comment with confidential information that you do not wish to be made public, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Access Public Comments
For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this document, into the "Search" box and follow the prompts, or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
For further information on meeting contact: Maya Thompson, Office of External Affairs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5335, Silver Spring, MD, 20993, phone: 301-837-7398, email: PublicEngagement@fda.hhs.gov.
Registration
Interested parties will have two options to attend this public meeting either in-person or virtually. Registration is free and based on space availability, with priority given to in-person registrants representing high priority areas for Domestic Manufacturing. Early registration is recommended because seating is limited. For this meeting, FDA is limiting the number of in-person participants per company/entity to facilitate a broad representation of the drug manufacturing industry. FDA will confirm registration for in-person participants based on the information requested above. Registrants that are not confirmed for in-person participation may join the meeting virtually. Persons interested in attending this public meeting in-person must register by September 2, 2025, 11:59 p.m. ET. If you need special accommodations due to a disability, please contact Maya Thompson, Office of External Affairs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5335, Silver Spring, MD, 20993, 301-837-7398, PublicEngagement@fda.hhs.gov no later than September 23, 2025, 11:59 p.m. ET.