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FDA acting commissioner Janet Woodcock discusses new agency plans to better secure the medical device supply chain.[ Price : $8.95]
The CBER Office of Compliance and Biologics Quality cautions The Dahlia Center that it is marketing unapproved cellular products.[ Price : $8.95]
FDA says Jordans Crossing Herbal Connection is marketing a misbranded unapproved new drug intended to prevent or treat Covid-19.[ Price : $8.95]
FDA grants AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA m...[ Price : $8.95]
Mintz attorneys say an FDA draft medical device remanufacturing guidance fails to give information that entities need to determine...[ Price : $8.95]
FDA grants Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating ad...[ Price : $8.95]
FDA clears a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator for man...[ Price : $8.95]
Covis asks FDA to determine that Eugia should have filed a 505(b)(2) NDA rather than an ANDA for its proposed generic form of Covi...