FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

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

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

Drug manufacturers' use of AI has recently increased significantly, according to the FDA. Here's how the agency says the ...

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

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

EMA and FDA define ten principles for AI use in medicines – in response to growing pressure from the industry.

MOLINE, Ill. — The Food and Drug Administration (FDA) has narrowed its guidelines on who should receive the updated COVID-19 vaccine. The changes mean fewer people are automatically eligible this year ...

NEW YORK — The 2025-2030 version of the Dietary Guidelines for Americans should be released this month and will emphasize whole foods, said Kyle Diamantas, deputy commissioner for human foods at the ...