FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
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 Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
New guidelines for healthy eating say Americans should eat more whole foods and protein, fewer highly processed foods and ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The new guidelines suggest prioritizing protein at each meal, with a goal of getting around 1.2 to 1.6 grams per kilogram of ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
NEW YORK — The 2025-2030 version of the Dietary Guidelines for Americans should be released this month and will emphasize ...