Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk Devices ...
AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...
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The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
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 ...
MedPage Today on MSNOpinion
Easing AI and Wearables Regulation Is a Risky Move
The FDA's planned rollback of oversight shifts risk onto patients and clinicians ...
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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 ...
(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 ...
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