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What to know about FDA’s new Digital Health Advisory Committee
The U.S. Food and Drug Administration recently created its first advisory committee for digital health. The emergence of digital health over the last several years and the recognition that some of these tools and applications inform direct health care delivery spurred this decision, said committee member Thomas Maddox, M.D., Maddox was a panelist at Health…
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Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition
Sanofi’s FDA Nod in Hemophilia Gives Patients More Convenience, Brings Roche New Competition FDA approval of Sanofi hemophilia A drug Altuviiio provides patients with a therapeutic option that lasts longer than most other products available, including one already marketed by the French pharma giant. Altuviiio also gives Sanofi a way to better compete against blockbuster…
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AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data
AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. Industry fumes as FDA increases AI tool regulation…
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Opinion: The Supreme Court doesn’t belong in your medicine cabinet
Opinion: The Supreme Court doesn’t belong in your medicine cabinet The silence from corporate America amid new attacks on women’s reproductive health care has been deafening. As the federal courts consider whether to override the FDA’s judgment on first-trimester abortion pills, it’s time for health care leaders to speak out about the repercussions of taking…
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‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system
‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system Soon after the Supreme Court overturned Roe v. Wade, a former Republican congressman made what might sound like an unusual offer. Did abortion pill makers want him to try to get federal legislation passed to explicitly stop states from…
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STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight
STAT+: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight Health tech companies are in a tizzy: After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance. In September,…
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FDA fines four companies for selling unapproved vapes
FDA fines four companies for selling unapproved vapes WASHINGTON — For the first time ever, the Food and Drug Administration has fined four businesses that have ignored its orders to stop selling unapproved vapes. The move is the latest escalation by the agency’s tobacco center, which has been criticized in recent months for allegedly standing…
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