Latest Federal Register Notices
Draft Guide on Fabry Disease Drug Development
Federal Register notice: FDA makes available a draft guidance on Fabry Disease drug development. 08/08/2019
Info Collection on IVD Study Informed Consent
Federal Register notice: FDA sends to OMB an information collection extension for its guidance on informed consent for in vitro diagnostic device studies. 08/08/2019
Annual Report on Postmarketing Requirements
Federal Register notice: FDA makes available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” 08/07/2019
FDA Revokes Emergency Use OK for Zika Test
Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA test. 08/07/2019
Annual Report on ‘Closed’ Advisory Panel Meetings
Federal Register notice: FDA releases an annual report on agency advisory committees that held closed meetings during fiscal year 2018. 08/07/2019
Nonvoting Member Needed on CBER Vaccine Panel
Federal Register notice: FDA seeks interested industry organizations to participate in selecting a nonvoting industry representative to serve on CBER vaccine/biological product panel. 08/06/2019
7 Info Collections Approved by OMB
Federal Register notice: FDA posts a list of seven information collections that have been recently approved by OMB. 08/06/2019
Biosimilar User Fee Rate for FY 2020 Set
Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2020. 08/05/2019