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

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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

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 ...

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

New FDA dietary guidelines urge people to eat more whole foods, cut down on ultra-processed items and reduce sugar intake, ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Pharmaceutical ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

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 ...