Guidance is not law, and frameworks should evolve. But the symbolism matters. At a moment when AI is entering clinical ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

The FDA has been called out for its refusal to ban formaldehyde in hair straightening products, jeopardizing the health of ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

One judge called Iowa's product registry “deadly” to manufacturers that can’t afford to recertify annually in different ...