miércoles, 14 de marzo de 2018

EUA amendments

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
Emergency Use Authorization
EUA amendments
  • March 8, 2018: In response to Hologic, Inc.'s request, FDA concurred (PDF, 130 KB) with the request to add processed whole blood K2EDTA as an authorized specimen under the EUA of the Aptima Zika Virus Assay issued on June 17, 2016. Additional information, including updated fact sheets
  • March 6, 2018: In response to CDC's request, FDA concurred (PDF, 85 KB) with an amendment to the Rafa Atropine Auto-Injector EUA for a change to a Rafa-planned manufacturing process. The Rafa Atropine Auto-Injector was initially authorized for emergency use for initial treatment of nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning in April 2017.  Additional information
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.

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