FDA Related News

Biologics

CBER AI/ML Web Page

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

Medical Devices

Fujifilm AI Colonoscopy Polyp Detector Cleared

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

Human Drugs

FDA OKs Tryvio as Add-on for Hypertension

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

Federal Register

Criteria on Difficult Compounding Lists

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

Human Drugs

J&Js Edurant PED Approved for Pediatric HIV-1

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

Human Drugs

FDA Warning Letters on Chinese Syringes

FDA sends Warning Letters to Jiangsu Shenli Medical Production Co. Ltd, a China-based plastic syringe manufacturer, and Medline Industries and Sol-Mil...

Human Drugs

FDA OKs Chronic Rhinosinusitis Nasal Spray

FDA approves an Optinose NDA for Xhance (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 y...

Marketing

Disease Awareness Ads Can Confuse: FDA Study

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

Digital Health Research Grants Available

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