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FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 18 hours ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
Monogram Provides Regulatory Update Following Meeting with FDA
Digital Journal· 11 hours agoFood and Drug Administration (the "FDA"). On April 19, 2024, Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission ...
To save lives, the FDA must change how it evaluates rare disease treatments
Salon via Yahoo News· 13 hours agoWe're urging the U.S. Food and Drug Administration to use regulatory tools, such as its accelerated...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 1 day agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
FDA Establishes CDER Center for Clinical Trial Innovation (C3TI) | JD Supra
JD Supra· 16 hours 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 ...
Bird flu virus test results are in: Cottage cheese and sour cream are safe, FDA says
Fast Company Magazine· 4 hours agoThe U.S. Food and Drug Administration said on Wednesday that preliminary results of additional...
Pfizer (PFE) Q1 2024 Earnings Call Transcript
Motley Fool via Yahoo Finance· 14 minutes agoWe have an increased demand for Xtandi, which continues to be a backbone therapy across the prostate cancer treatment continuum. And we have continued...
Ohio company gets greenlight from FDA to test Cuban drug for diabetic foot ulcers
The Cleveland Plain Dealer· 49 minutes agoCLEVELAND, Ohio— Cleveland-based biotechnology company Discovery Therapeutics Caribe will soon be...
A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs |...
JD Supra· 16 hours agoOn April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced ...
Bird flu testing shows more dairy products are safe, US FDA says
Reuters· 5 hours agoThe U.S. Food and Drug Administration said on Wednesday that preliminary results of additional...
