Federal legislation is the best opportunity to compel pharmacy benefit managers (PBMs) to change. Neither a major Federal Trade Commission (FTC) settlement nor reforms at the state level have fixed market distortions. But the upcoming US midterm elections in November...

As Head of R&D at a Swiss cosmetics laboratory, I read a lot of the evidence behind the cosmetic actives that brands ask us to put in their formulas. The same pattern keeps turning up. A well-cited in-vitro mechanism gets marketed as if it were a proven clinical...

Medical device manufacturers have long relied on third-party technology. Generative AI, however, presents new challenges for manufacturers of AI medical devices, who may have little influence over how the external model is developed. The technology may be outside of...

Longan was a familiar food in the home I grew up in. It was a tasty summer fruit we ate in southern China, much like an American family might think of mango. Years later, when I started making beverages in St. Louis, I used longan in a hydration drink, well before FDA...

Six decisions that shape FDA readiness for software as a medical device and connected digital health products A software team can build a compelling product and still reach the submission stage with a fundamental problem: the evidence supports a narrower claim than...