Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
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Six months “a very limited window” for medical device shortage flaggingBeta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...
Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...
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