Emergency Use Authorization and related updates

EUA updates

August 3, 2018: EUA amendment - DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.) - more info August 7, 2018: Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines - The HHS Secretary is amending the August 1, 2016 Declaration to extend the effective time period of the declaration through December 31, 2022 and to clarify and add to the list of covered countermeasures to include all Zika virus vaccine types and technologies. Also see PREP Act Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer. Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.