On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.
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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual disease (MRD) and complete response (CR) as primary end points in clinical ...
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...
In a pilot, Utah is testing use of AI for renewing drug prescriptions. Experts ask if it should be regulated as a medical ...
In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to ...
The Food and Drug Administration (FDA) announced Thursday it will not enforce federal regulations regarding “false or ...
(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 ...
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 ...
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...
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