On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
The Food and Drug Administration (FDA) announced Thursday it will not enforce federal regulations regarding “false or misleading” material on food labeling in regard to artificial food dyes, giving ...
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...
The Food and Drug Administration said Thursday that it will not enforce regulations against "false or misleading" material on ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
In a pilot, Utah is testing use of AI for renewing drug prescriptions. Experts ask if it should be regulated as a medical ...
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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
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 ...
This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to ...
Novo warned on Wednesday of unprecedented price pressure on its weight-loss medicines and dropped its full-year forecast, ...
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