The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers

AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
National Law Review

FDA Updates Two Digital Health Final Guidance Documents

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...
JD Supra

FDA Adapts with the Times on Digital Health: Updated Guidances on General Wellness Products and Clinical Decision Support Software

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel

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 ...
Medical Device and Diagnostic Industry (MD+DI)

CGM Manufacturer Views FDA’s New Rules on Wearables as “Catalyst” for Accelerated Commercialization

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Food Dive

FDA moves toward tougher gluten labeling rules

The agency issued a request for more information that will shape new regulation on ingredient transparency.
Targeted Oncology

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
JD Supra

FDA Food Chemical Regulation After the MAHA Executive Order

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
MobiHealthNews

Should mHealth companies want FDA regulation?

(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 ...