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

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

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

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

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

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

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 ...

FDA officials told GAO that competing priorities and an agency reorganization in late 2024 have slowed progress, estimating ...