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March 17, 2017  |  FDA Medical Countermeasures Initiative Update

MCMi FY 2016 program update

Learn how FDA facilitates development of and access to MCMs

As we have since the Medical Countermeasures Initiative (MCMi) was launched in 2010, FDA continues our ongoing work to advance the development and availability of medical countermeasures (MCMs) to protect against chemical, biological, radiological, and nuclear (CBRN) threats, and emerging infectious diseases, like Ebola and Zika. This report covers these activities for fiscal year 2016, including MCM-related regulatory science and legal and policy actions.
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Zika Update

FDA informs collection establishments of CDC-identified potential increased Zika virus risk to blood and tissue safety in Florida’s Miami-Dade, Palm Beach, and Broward counties
On March 13, 2017, the Centers for Disease Control and Prevention (CDC) announced that based on a retrospective analysis of Zika virus (ZIKV) infections they identified a potential increased risk to blood and tissue safety, including semen, in Florida’s Miami-Dade, Palm Beach, and Broward counties dating back to June 15, 2016. While Miami-Dade County is the only part of Florida currently (July 29, 2016 to present) designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention, people in this part of Florida regularly travel within and between these three counties and may not recognize that they have been in an area of active ZIKV transmission.
This information has been added to CDC’s webpage used to communicate epidemiological information about ZIKV to the blood and tissue collection community.
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EUA amendments

  • March 6, 2017 - RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
  • March 1, 2017 - CDC Trioplex Real-time RT-PCR Assay (CDC)
  • February 28, 2017 - Zika Virus Real-time RT-PCR Test (Viracor Eurofins)
More information about EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, implemented in November 2016.
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