Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments

摘要

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.