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 ...
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.
On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy ...
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...
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 ...
Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved ...
PharmaEssentia Announces Updated NCCN Clinical Practice Guidelines Include ropeginterferon alfa-2b-njft (BESREMi®) for ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results