Worldwide: Food, Drugs, Healthcare, Life Sciences

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

Partner Jason Schultz explores the evolving role of in-house counsel in healthcare organizations, identifying five critical capabilities that legal professionals must develop to remain effective strategic partners. The article examines how modern healthcare lawyers can enhance their value by mastering skills beyond traditional legal expertise, including project management, emotional intelligence, and business acumen.

The FDA has issued a Request for Information on a proposed AI-enabled optimization pilot program for early-phase clinical trials, signaling a shift toward "trustworthy AI" principles aligned with NIST frameworks.

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

On May 12, 2026, the U.S. Food and Drug Administration (FDA) announced a major milestone in its approach to post-market oversight of chemicals in the food supply, finalizing a new proactive food chemical safety post-market assessment program...

New Jersey's Protecting Against Forever Chemicals Act prohibits intentionally added PFAS in consumer products like cosmetics, carpets, and food packaging starting January 2028, while imposing strict labeling requirements for cookware manufacturers. The legislation establishes comprehensive enforcement mechanisms with civil penalties up to $25,000 per day and mandates state-level source reduction programs and environmental monitoring.

What does it take to build a culture of excellence in healthcare? Dr. Ryan Molli, founder and CEO of Whole Health Orthopedic Institute, shares his journey from rural Pennsylvania to launching his own practice...

A massive 320-page class action complaint filed on May 4, 2026, in the U.S. District Court for the Northern District of Illinois has the attention of the cannabis sector. The insurance professionals who underwrite it should also be paying close attention. The case, Murray et al. v. Cresco Labs Inc. et al., represents the most ambitious legal assault yet on the marketing practices of major cannabis multistate operators (MSOs).

On May 13, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a press release and a Federal Register notice announcing a nationwide moratorium on the enrollment of new home health agencies (HHAs) and hospices, effective immediately. Under the moratorium, new providers are barred from enrolling in Medicare as HHAs or hospices for a six-month period.