Three additional state privacy laws have recently taken effect, continuing the steady expansion of privacy regulation in the United States. With these additions, the U.S. now has twenty comprehensive state privacy laws on the…
more
/ Commercial Law & Contracts, Privacy, Science, Computers, & Technology
Journal articles presenting new ways to diagnose and treat diseases appear almost daily. They offer promise for patients currently suffering from disease and for those patients who may face these conditions in the future…
more
/ Administrative Law, Health, Science, Computers, & Technology
On February 5, 2026, the U.S. Food and Drug Administration (FDA) issued Letter to the Food Industry on “No Artificial Colors” Labeling Claims announcing a revised enforcement policy regarding “no artificial colors” labeling…
more
/ Administrative Law, Consumer Protection, Health
A growing number of companies across the U.S., including medtech, biotech, pharma, cosmetic, food and beverage, and other life sciences companies are receiving demand letters and complaints alleging that common website…
more
/ Health, Privacy, Science, Computers, & Technology
On January 16, 2026, the U.S. Department of Justice announced that False Claims Act (FCA) settlements and judgments for Fiscal Year 2025 exceeded $6.8 billion, the highest annual total in the statute’s history. Recoveries more…
more
/ Commercial Law & Contracts, Government Contracting, Health, Science, Computers, & Technology
The advertising and promotion process creates many headaches for medtech companies. The start of a new year is a natural time to assess whether your current process is working as intended or creating unnecessary friction…
more
/ Communications & Media Law, Health
In December 2025, the U.S. Food and Drug Administration (FDA) sent an Untitled Letter to BeOne Medicines USA, Inc., raising concerns about the company’s use of branded Microsoft Teams backgrounds to promote TEVIMBRA injection…
more
/ Administrative Law, Communications & Media Law, Health
Food manufacturers should be paying close attention. People of the State of California v. Kraft Heinz Company, Inc., et al., a first-of-its-kind lawsuit brought by the San Francisco City Attorney against several major food…
more
/ Administrative Law, Consumer Protection, Health
Medical products manufacturers should be deep into reporting season planning. The federal Physician Payments Sunshine Act and Open Payments Program deadline is March 31, 2026, and it covers transfers of value made during…
more
/ Administrative Law, Health
On January 21, 2026, a group of dietary supplement companies filed a complaint in the U.S. District Court for the District of Columbia challenging FDA’s denial of over 100 proposed health claims for dietary supplements. The…
more
/ Administrative Law, Consumer Protection, Health
Federal lawmakers are advancing multiple bills that would significantly reshape how substances are designated Generally Recognized as Safe (GRAS) and how they are evaluated, disclosed, and regulated. While the bills vary in…
more
/ Administrative Law, Agriculture, Health
Medical device and pharmaceutical manufacturers regularly face commercial contracting challenges in a complex healthcare environment. Whether a manufacturer is a small start-up or a large global organization, it operates under…
more
/ Business Organizations, Commercial Law & Contracts, Health
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the FDA Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Digital…
more
/ Health, Privacy, Science, Computers, & Technology
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates provide important clarification on how certain products may fall within, or outside, FDA oversight…
more
/ Health, Science, Computers, & Technology
Privacy and artificial intelligence (AI) regulation and enforcement have been heating up in the U.S. and around the world. What should device and drug makers expect in 2026?…
more
/ Health, Privacy, Science, Computers, & Technology
