FDA issues a guidance on Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices Questions a...
FDA updates a guidance entitled Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD...
FDA faces another Covid-19 debacle as it deals with over 1,300 Chinese firms providing medical protective equipment that registered in FDAs database w...
FDA Review posts product approval summaries for the week ending 6/21/2020.
FDA approves the expansion of a USGI Medical pilot study of it obesity-treating endoscopic procedure known as POSE 2.0.
Mylan says it is urging FDA to speed up its review of the companys ANDA for a generic copy of Biogens multiple sclerosis (MS) drug Tecfidera (dimethyl...
FDA posts a guidance entitled Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Prod...
Federal Register notice: FDA announces a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BL...