Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

The U.S. Food and Drug Administration ("FDA") recently issued updated final guidance documents on general wellness products and clinical ...

The post The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers appeared first on Reason.com.

New FDA dietary guidelines urge people to eat more whole foods, cut down on ultra-processed items and reduce sugar intake, warning that modern packaged diets are driving obesity, diabetes and ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...

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

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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