Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the United States. FDA is also announcing the following public meeting entitled "Onshoring Manufacturing of Drugs and Biological Products." At this meeting, FDA will present a draft framework that seeks to facilitate onshoring of pharmaceutical manufacturing. Participants will then engage in a guided discussion regarding the proposed framework, its strengths, weaknesses, and opportunities. The group will also discuss additional considerations that may help overcome current challenges faced by industry to onshoring the manufacturing of pharmaceuticals, including active pharmaceutical ingredients (APIs) and finished drug and biological products, and ideas and options within the bounds of FDA's statutory authority that could facilitate such onshoring of manufacturing.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2025-N-2489] ( printed page 38475) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the United States. FDA is also announcing the following public meeting entitled “Onshoring Manufacturing of Drugs and Biological Products.” At this meeting, FDA will present a draft framework that seeks to facilitate onshoring of pharmaceutical manufacturing. Participants will then engage in a guided discussion regarding the proposed framework, its strengths, weaknesses, and opportunities. The group will also discuss additional considerations that may help overcome current challenges faced by industry to onshoring the manufacturing of pharmaceuticals, including active pharmaceutical ingredients (APIs) and finished drug and biological products, and ideas and options within the bounds of FDA's statutory authority that could facilitate such onshoring of manufacturing. DATES: The hybrid public meeting will be held on September 30, 2025, from 9:00 a.m. to 4:00 p.m. Eastern Time and will take place in person and virtually. Either electronic or written comments on this public meeting must be submitted by October 30, 2025…
Citation: 90 FR 38475
