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FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 12 hours agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests ...
Weight loss drug shortage: Zepbound and Wegovy in short supply, says FDA
BenefitsPRO· 16 hours agoThe U.S. Food and Drug Administration updated its drug shortage database in April to reflect that...
FDA Qualifies Apple Watch's AFib History For Use In Clinical Studies - Slashdot
Slashdot· 3 hours agoIn a first for "digital health technology," the Apple Watch's atrial fibrillation (AFib) history feature has been approved by the FDA to join the FDA's ...
Apple Watch series AFib monitor getting FDA medical certification
Android Headlines· 8 hours agoThe Apple Watch series AFib feature has received new approval from the FDA. From now on, the results...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI· 19 hours agoMost of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may...
Can You Get Bird Flu From Eggs and Milk? Everything to Know About Avian Influenza
Glamour via Yahoo News· 6 days agoThe FDA says 20% of retail milk samples have tested positive for bird flu “viral fragments.” We...
FDA finalizes lab test regulations with more flexibility
Politico· 3 days agoThe new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal. Chief among them is a grandfathering clause which means ...
Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with...
WKBN 27 Youngstown· 19 hours agoFood and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor ...
FDA Brings Lab Tests Under Its Oversight
MedPage Today· 4 days agoThe FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday. LDTs are in vitro diagnostic products (IVDs)...
Should you be worried about bird flu in your milk? Food safety expert explains the dangers of...
Medical Xpress· 10 hours agoThe FDA said one in five samples tested positive for traces of the highly pathogenic avian...