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Biopharma leaders and pediatric rare disease experts gathered for the FDA's ADEPT 10 workshop to discuss paths to advance neonatal drug development. This is the definitive recap.
During the FDA's Digital Health Advisory Committee Meeting, the FDA, clinicians, payers, and developers discussed how generative AI mental health devices can expand access without compromising safety. Here's what happened.
The FDA's final guidance on clinical decision support (CDS) regulation is causing a stir. Here's a summary for physicians on what it's about.
As part of its commitment to supporting innovation as well as safety and effectiveness, the FDA has been giving artificial intelligence (AI) a lot of attention over the past few years. One topic of discussion centers …
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