FDA acting commissioner Janet Woodcock discusses new agency plans to better secure the medical device supply chain.
The CBER Office of Compliance and Biologics Quality cautions The Dahlia Center that it is marketing unapproved cellular products.
FDA says Jordans Crossing Herbal Connection is marketing a misbranded unapproved new drug intended to prevent or treat Covid-19.
FDA grants AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection...
Mintz attorneys say an FDA draft medical device remanufacturing guidance fails to give information that entities need to determine if their activities...
FDA grants Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating adult patients with pr...
FDA clears a Zoll Medical 510(k) for its TBI Dashboard feature on its Propaq M monitor and Propaq MD monitor/defibrillator for managing patients with ...
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 Covis Makena Autoinjecto...