On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
In a pilot, Utah is testing use of AI for renewing drug prescriptions. Experts ask if it should be regulated as a medical ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Mario Aguilar covers technology ...
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
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 ...
Robert F. Kennedy Jr. speaks at his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. (Photo: Lydia Johnson) The Food and Drug Administration will consider ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results