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

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

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

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

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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 announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The U.S. Food and Drug Administration may soon convert an entire generation of U.S. children, especially children in foster ...

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

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