On February 17, 2026, the Health Resources and Services Administration (HRSA) published a Request for Information (RFI) in the Federal Register seeking input on the potential implementation of a rebate model under the 340B...more
The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for Cosmetic Products: Guidance for Industry" (the “Draft Guidance”). The Draft Guidance...more
On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory Bulletin (the “SAB”) addressing key considerations for pharmaceutical manufacturers' offering...more
Congress Probes Chinese Biotech GLP-1 Product Compliance -
Although the FDA recently implemented additional safeguards related to imported GLP-1 products, the safety of GLP-1 active pharmaceutical ingredient (“API”)...more
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) software. The January 2026 guidance supersedes the previous, and less detailed,...more
On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad introducing the concept of...more
Katten's Privacy, Data and Cybersecurity Quick Clicks is a monthly newsletter highlighting the latest news and legal developments involving privacy, data and cybersecurity issues across the globe....more
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs) for generic drugs that utilize U.S.-based manufacturing and testing. Announced on October...more
The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to “advance a broader discussion among the AI healthcare ecosystem.” Specifically, the FDA has issued a Request for...more
Katten's Privacy, Data and Cybersecurity Quick Clicks is a monthly newsletter highlighting the latest news and legal developments involving privacy, data and cybersecurity issues across the globe....more
9/26/2025
/ Artificial Intelligence ,
Data Protection ,
Enforcement Actions ,
EU ,
Food and Drug Administration (FDA) ,
Healthcare ,
New Legislation ,
Online Safety for Children ,
Popular ,
Texas ,
UK
On September 9, 2025, the U.S. Food and Drug Administration (FDA) announced it is launching a targeted initiative to combat deceptive drug advertising. According to the announcement, the FDA sent thousands of letters warning...more
On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced the establishment of a "green list" import alert (Import Alert 66-80) designed to prevent unverified glucagon-like peptide-1 (GLP-1) active...more
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