Here's full footage from a STAT event with former top FDA official Richard Pazdur, who expressed grave concern about ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
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 ...
1don MSN
Legal questions swirl around FDA’s new expedited drug program, including who should sign off
FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...
More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new ...
WEST MICHIGAN — Menopause is the term to describe women no longer receiving natural estrogen from her ovaries, and for several years, women who would be excellent candidates for Menopause Hormone ...
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 ...
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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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