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

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 ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

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

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...

There are concerns among local dietitians over the new nutrition guidelines coming out of the FDA. While they support the FDA ...

New guidelines for healthy eating say Americans should eat more whole foods and protein, fewer highly processed foods and ...