Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
Generally Recognized as Safe reform, food chemical safety reviews, and expanding the role of state agencies in the food ...
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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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 ...
The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...
(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 ...
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
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