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FDA Announces Final Regulation Governing Laboratory Developed Tests | JD Supra
JD Supra· 1 day agoThe U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will ...
FDA Approves New Treatment for Urinary Tract Infections, What to Know
Healthline· 6 days agoThe Food and Drug Administration (FDA) recently approved a new antibiotic to treat urinary tract...
Bird flu testing shows more dairy products are safe, US FDA says
AOL· 14 hours agoNEW YORK (Reuters) -The U.S. Food and Drug Administration said on Wednesday that preliminary results of additional testing of more dairy products has shown that pasteurization inactivates the ...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI· 9 hours agoMost of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI via Yahoo News· 9 hours agoIn a move that health experts say may reduce the number of fentanyl deaths, the FDA has approved over-the-counter sales of Narcan nasal spray. Now that it is more readily ...
FDA Establishes CDER Center for Clinical Trial Innovation (C3TI) | JD Supra
JD Supra· 1 day agoC3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making. As ...
FDA approves first targeted therapy for WHIM syndrome By Investing.com
Investing.com· 3 days agoX4 Pharmaceuticals (NASDAQ:XFOR) announced today the U.S. Food and Drug Administration (FDA) has...
BrioHealth Solutions Secures Nod from FDA to Begin the INNOVATE Trial Featuring the BrioVAD™ System...
FOX 59 Indianapolis· 17 hours agoBrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA Investigational ...
FDA finalizes rule to increase oversight of lab tests
CQ Politics· 3 days agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
The FDA and Gene Therapy for Duchenne Muscular Dystrophy
Journal of the American Medical Association· 1 day agoThe US Food and Drug Administration (FDA) grants accelerated approval that includes the standard of a surrogate outcome that is “reasonably likely” to predict clinical benefit ...