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CBER AI/ML Web Page

[ Price : $8.95]

CBER launches a new Web page on its approach to using AI/ML in regulatory oversight of products it regulates.

Fujifilm AI Colonoscopy Polyp Detector Cleared

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FDA clears a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging.

FDA OKs Tryvio as Add-on for Hypertension

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FDA approves an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs i...

Criteria on Difficult Compounding Lists

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Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonst...

J&Js Edurant PED Approved for Pediatric HIV-1

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FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in...

Panel to Discuss Non-invasive Ocular Pump

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FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lo...

Key Patient Long Covid Meeting Themes

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FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.

Disease Awareness Ads Can Confuse: FDA Study

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CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and ...

Digital Health Research Grants Available

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FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.