FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
In an interview with Bloomberg News, Eli Lilly Chief Financial Officer Lucas Montarce said that the Indiana-based pharma ...
FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades-old "black box" warnings on many hormone therapy drugs used for ...
More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...
The FDA is apparently not charmed by the mischievous “Lipid Lurkers” in an Esperion Therapeutics commercial for ...
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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 ...
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