U.S. FDA

@FDA

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Silver Spring, MD

Joined October 2010

U.S. FDA
@FDA
15h
FDA just released a white paper on digitally derived measures (DDMs), explaining how wearables & #AI can capture real-time, real-life health outcomes that goes beyond the clinic visit. Digital health technologies (DHTs) are expanding what we understand about a participant's
FDA Weighs in on the Development and Use of Digitally Derived Measures
From fda.gov
U.S. FDA
@FDA
Aug 19
Today, we approved a one-time gene therapy product for treatment as an adjunct to nutritional management of patients 8 years of age and older with glycogen storage disease type Ia (GSDIa). This is the first therapy approved for this condition in patients 8 and older.
U.S. FDA
@FDA
Aug 18
Under @POTUS and @SecKennedy’s leadership, the FDA is fundamentally reshaping how we oversee AI-powered medical devices. Moving beyond outdated regulatory models, our new discussion papers introduce a bold, “competency-based” framework - a major win for innovation, patient
U.S. FDA
@FDA
Aug 18
Join FDA’s Office of Women’s Health & the Center for Drug Evaluation and Research for a hybrid public workshop on testosterone use in menopausal women on 9/17. Register & submit public comments on this important issue: fda.gov/consumers/wome… #Menopause
U.S. FDA
@FDA
Aug 18
The FDA is seeking public input on considerations for the regulation of generative AI-enabled medical devices. We’ve put out a discussion paper, and we’re inviting feedback by October 19, 2026. fda.gov/news-events/pr…