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Sharfstein et al. Urge Stronger FDA Oversight of Accelerated Approvals
FDA should strengthen its oversight and enforcement of confirmatory trials for accelerated approval drugs, with Medicare and Medicaid payments limited until the products’ clinical benefits are confirmed, according to a new proposal for expanding the agency's role in addressing drug costs. The proposal is one of several recommendations
FDA Actions Signal Scrutiny of Telehealth Prescribing Models: Attorneys
Recent FDA enforcement activities could signal increased scrutiny of telehealth platforms that facilitate prescribing of compounded drugs, particularly when technology or standardized processes may undermine individualized clinical decision-making, according to attorneys at ArentFox Schiff. In an 10/5 Insights post, attorneys Abha Kundi and Matthew Berlin noted FDA'
AI Model Detects Pancreatic Cancer Before Visible on CT Scans
An artificial intelligence (AI) model detected pancreatic cancer on routine CT scans more than a year before clinical diagnosis and substantially outperformed expert radiologists in identifying early cancers that were not yet visually apparent, according to a study published in BMJ’s Gut. Researchers led by Mayo Clinic developed a
TikTok Misinformation on Acetaminophen, Autism Surged After FDA Notice
Misinformation on TikTok linking acetaminophen use during pregnancy with autism surged following a 9/2025 FDA announcement (see story) on the issue, with misleading videos attracting disproportionate attention, according to research presented at the American Academy of Pediatrics' 2026 National Conference & Exhibition. Researchers analyzed 53 TikTok videos posted