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

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

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

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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

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

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

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 ...

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

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