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...
The CBER Office of Compliance and Biologics Quality says A Better Life Stem Cell Center is marketing unapproved cellular products that it terms stem c...
An Evaluate Vantage post says FDA approval of high-risk medical devices has dropped in the first half of 2021 due to workload strains caused by Covid-...
FDA says Pfizer is expanding its Chantix recall and Apotex can temporarily distribute some of its generic Chantix product in the U.S. with levels of a...
A Business Group on Health study group recommends changes to the pharmaceutical supply chain system to counter government drug pricing regulations.