FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.

The FDA announced it will relax certain rules for approving low-cost versions of some high-priced medications.

In any review of mifepristone, the FDA will now have to grapple with Judge Otake’s conclusion that the 2023 REMS decision for ...

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...

Texas Attorney General Ken Paxton has asked a federal judge to force the makers of Tylenol to stop any advertising that the ...

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...

Direct-to-consumer drug advertising is already the most heavily regulated form of commercial speech in America. It does not need more.

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

The Utah Dental Association (UDA) has issued an urgent guidance days after the U.S. Food and Drug Administration (FDA) moved ...