Articles: 1-10 of 124
A “New Era” of Consumer Medicine? FDA Takes Another Swipe at “Unapproved” Compounded Drugs
USA - March 9 2026 For years, the commercial compounding and telehealth industry blossomed, buoyed by exploding consumer interest in GLP-1s and other compounded drugs…
What to Watch: OPDP Off to a Roaring 2026
USA - February 12 2026 Operating at full capacity thus far this year, the U.S. Food and Drug Administration (“FDA” or “agency”) Office of Prescription Drug Promotion…
2026 Top-of-Mind Issues for Life Sciences Companies
European Union, USA - February 11 2026 In 2010, the Obama Administration largely disrupted the healthcare industry with its landmark legislation, the Affordable Care Act. We are in another…
The CLEAR LABELS Act Proposes Changes to the U.S. Prescription Drug Supply Chain
USA - February 4 2026 Last week, Senator Rick Scott introduced the Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings…
Of Drugs and DTC Platforms: American Consumerism, TrumpRx, Telehealth, and the Specter of Congressional Intervention
USA - February 3 2026 Debated is the genesis of the first direct-to-consumer (DTC) drug concept in the U.S. Going back to at least 2011, Pfizer’s “unorthodox” Diplomat…
“Deregulation” on the Menu: Big Changes for Wellness and CDS Technologies
USA - January 14 2026 Last week, the U.S. Food and Drug Administration (“FDA”) rung in the New Year with a flurry of device-related activity, updating two final guidance…
FDA Continues Crack Down on DTC Advertising: Untitled Letter Highlights Pitfalls in Schizophrenia Drug Promotion
USA - January 7 2026 Just in time for the holidays, on December 15, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”)…
What to Watch: Continued DTC Advertising Enforcement
USA - December 2 2025 Just before Thanksgiving, the Food and Drug Administration’s (“FDA’s”) Office of Prescription Drug Promotion (“OPDP”) silently published three…
Congress Joins the Biomanufacturing Onshoring Party
USA - November 20 2025 In mid-November 2025, Congress introduced the Biomanufacturing Excellence Act of 2025 (H.R. 6089) to establish a dedicated national center aimed at…
Texas Sues Johnson & Johnson and Kenvue Over Tylenol: Scientific Evidence, Regulatory Shifts, and the Future of OTC Drug Labeling
USA - November 4 2025 On October 28, 2025, the State of Texas filed a complaint against Johnson & Johnson and Kenvue, Inc. (“Kenvue”)—formerly the consumer health division…
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