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

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

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

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 ...

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

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

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 ...

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food 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 ...

Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...