On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more
On July 9, 2025, the Federal Trade Commission (“FTC”) hosted a workshop to discuss unfair and/or deceptive trade practices in gender affirming care (“GAC”) for minors. During this webinar, the FTC indicated it would be...more
On July 15, the U.S. Secretary of Agriculture, Brooke L. Rollins, announced a “comprehensive plan to bolster U.S. Department of Agriculture’s (“USDA”) efforts to combat foodborne illness” and better position USDA Food Safety...more
In a significant move toward greater labeling transparency and state oversight of food policy, Texas and Louisiana have enacted new laws requiring special labels and disclosures for certain food ingredients. Aimed at...more
On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more
On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more