HCT/Ps

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In mid-November 2025, Congress introduced the Biomanufacturing Excellence Act of 2025 (H.R. 6089) to establish a dedicated national center aimed at strengthening U.S. capacity for biopharmaceutical manufacturing. The bipartisan bill signals a material alignment with the current administration’s onshoring and domestic innovation-fostering policy and presents meaningful scale-up opportunities for drug, device, and human-cell/tissue product sponsors that are part of institutions or public-private partnerships.Continue Reading Congress Joins the Biomanufacturing Onshoring Party

Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is a collection of seemingly contradictory signals, keeping us guessing as to whether we will see an increase or decrease in HCT/P regulation – either by written regulation or enforcement. To date, aside from some recent enforcement,[2] not a whole lot has changed.Continue Reading What to Watch: Human Cell and Tissue Product Regulation