Federal Register notice: FDA determines that Promius Pharmas Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons...
FDA commissioner Stephen Hahn praises agency medical product review staff for maintaining the pace of reviews and actions during the pandemic.
Democratic leaders of the House Committee on Oversight and Reform ask FDA for a briefing on plans for coronavirus vaccine transparency to build public...
Two SheppardMullin attorneys discuss provisions in an FDA guidance on preventing coronavirus contamination of drugs, biologics, and APIs.
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...
FDAs Center for Veterinary Medicine launches its Export Certification Application and Tracking System, a new online system that allows U.S. animal foo...