News
New device QMSR includes significant changes for combination products
30+ min ago (227+ words) The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes in the regulatory framework for combination drug-device and biologic-device products, especially those overseen through approved applications by the Center for Drug Evaluation and Research (CDER)…...
Puerto Rico Influenza Health Emergency Triggers Special Paid Sick Leave
35+ min ago (587+ words) On January 27, 2026, Puerto Rico Governor Jennifer Gonz'lez Col'n issued Executive Order 2026-005 declaring a public health national emergency due to epidemic-level influenza cases, effective immediately. The national emergency declaration activates the special five-day paid sick leave requirements under Puerto Rico law…...
OIG Issues Special Advisory Bulletin on Direct-to-Consumer Drug Programs
1+ hour, 7+ min ago (387+ words) The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Advisory Bulletin on January 27 addressing how the federal Anti-Kickback Statute (AKS) applies to pharmaceutical manufacturers' direct-to-consumer (DTC) prescription drug programs. The bulletin follows Executive…...
Scope of Products Requiring Proposition 65 Warnings in California Poised to Grow
1+ hour, 33+ min ago (721+ words) The scope of products to be drawn into the warning requirements under California's Proposition 65 law may soon be growing. California's Office of Environmental Health Hazard Assessment (OEHHA) requested information from the public on the reproductive toxicity of p,p'-bisphenol…...
FDA Seeks Information on Gluten Ingredient Disclosures in Packaged Foods
2+ hour, 2+ min ago (312+ words) On January 21, 2026, the U.S. Food and Drug Administration ("FDA") announced a Request for Information regarding labeling of and adverse reactions to gluten in packaged food....By: Venable LLP FDA Seeks Information on Gluten Ingredient Disclosures in Packaged Foods On January 21, 2026, the…...
FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
2+ hour, 20+ min ago (432+ words) In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to show the effectiveness of a new drug....By: Goodwin FDA Issues Guidance on Modernizing Statistical Methods for…...
PBM Reform Picks Up Pace with Enactment of Consolidated Appropriations Act, PBM Fee Disclosure Proposed Rule
2+ hour, 22+ min ago (116+ words) Pharmacy benefit manager (PBM) reform has been an active and evolving area for policymakers in Washington, D.C. for many years but reform efforts have noticeably picked up pace in 2026. Recent actions by Congress and the Trump administration underscore how PBM reform…...
When the Rules Changed: The Top 2025 Privacy and Security Issues Still Shaping Healthcare
2+ hour, 25+ min ago (188+ words) 1. Major HIPAA Security Rule Changes on the Horizon Authored by Taylor White and Lisa Luetkemeyer 2. Reproductive Health Privacy Rule Vacated Authored by Kasey Ciolfi and Wendy Keegan 3. 2025 State Privacy Changes'What Healthcare Leaders Need to Know Authored by Colleen Pert and…...
Hospitals: Prepare now for mandatory provider-based attestation process
2+ hour, 28+ min ago (188+ words) All hospitals that are paid under the Medicare Outpatient Prospective Payment System and operate off-campus outpatient departments should prepare for submission of mandatory provider-based attestations (PBAs), even if they have submitted them in the past....By: McDermott Will & Schulte While…...
The Need for Comprehensive Governance of AI Use in Health Care Settings
2+ hour, 40+ min ago (616+ words) A recent survey of more than 100 physicians across more than 200 specialties found that 67% use artificial intelligence (AI) tools daily in their practice, whether for scheduling, diagnostics, patient care, billing, or electronic health record management (Offcall)....By: Brooks Pierce The Need…...