Emergency Preparedness and Response

MCMi News and Events

collage of images illustrating medical countermeasures
News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners. This page is updated frequently.

  • August 17, 2016: FDA issued an EUA for emergency use of InBios International, Inc.’s ZIKV Detect™ IgM Capture ELISA for the presumptive detection of Zika virus IgM antibodies in human sera. This is the first commercially available serological test for Zika available under EUA (the first serological test, the CDC Zika MAC-ELISA, was initially authorized for use in February 2016).  Also see Zika Emergency Use Authorization information - Additional technical information

  • August 4, 2016: FDA issued an EUA to authorize the emergency use of Luminex Corporation’s  xMAP® MultiFLEX™ Zika RNA Assay for the qualitative detection of RNA from Zika virus in human serum, plasma, and urine. Also see Zika Emergency Use Authorization information - Additional technical information

  • July 29, 2016: FDA issued an EUA to authorize emergency use of Siemens Healthcare Diagnostics Inc.’s VERSANT® Zika RNA 1.0 Assay (kPCR) Kit for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine. Also see Zika Emergency Use Authorization information - Additional technical information

  • July 19, 2016: FDA issued an EUA to authorize emergency use of Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test (Viracor-IBT) for the qualitative detection of RNA from Zika virus in human serum, plasma or urine. Also see  Zika Emergency Use Authorization information - Additional technical information

  • June 26, 2016: In response to CDC's request to amend the CDC Zika MAC-ELISA EUA, FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments incorporated. The amendments (PDF, 494 KB): (1) update the language for the CDC Zika virus clinical and epidemiological criteria; (2) update the language related to additional testing of positive or equivocal test results using the CDC algorithm; (3) allow use of Zika COS-1 Recombinant Antigen (CDC catalog #AV0005) as Zika Viral Antigen in addition to Lyophilized Zika Vero E6 Tissue Culture Antigen (CDC catalog #AV002 or AV003); and (4) as described in Section IV. More

  • June 17, 2016: FDA issued an EUA to authorize emergency use of Hologic, Inc.’s Aptima Zika Virus assay, a test to help detect Zika virus infection in people who have symptoms of Zika virus infection, and live in or have traveled to an area with active Zika virus transmission. This test is intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Additional technical information

  • May 26, 2016: FDA issued an EUA to authorize the emergency use of the Idylla™ Ebola Virus Triage Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the Idylla™ Instrument System (Idylla™ System) in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Idylla™ Ebola Virus Triage Test should be performed by laboratories in CLIA moderate and high complexity laboratories in the U.S. or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Idylla™ Ebola Virus Triage Test on the Idylla™ System. Additional technical information
  • May 13, 2016: FDA  issued an EUA to authorize emergency use of the altona Diagnostics GmbH RealStar Zika Virus RT-PCR Kit U.S. to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in or have traveled to an area with active Zika virus transmission. This test is intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. This is the first commercial Zika diagnostic test that will be available for purchase by labs and will include serum and urine specimens. Additional technical information
  • April 28, 2016: FDA issued an EUA to authorize emergency use of Focus Diagnostics, Inc.'s Zika Virus RNA Qualitative Real-Time RT-PCR test to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in or have traveled to an area with ongoing Zika virus transmission. This is the first commercial test to detect Zika virus that has been authorized by FDA for emergency use. Additional technical information
  • April 13, 2016: FDA issued two Emergency Dispensing Orders to facilitate anthrax preparedness for stakeholders. FDA issued these orders in collaboration with CDC, which issued Emergency Use Instructions (i.e., fact sheets) for these two products: doxycycline and ciprofloxacin. The emergency dispensing order authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization. More about emergency use of approved MCMs
  • April 1, 2016: Draft Guidance - Emergency Use Authorization of Medical Products and Related Authorities (Federal Register notice) - comment by June 3, 2016
  • December 2015: The HHS Secretary has amended seven Public Readiness and Emergency Preparedness (PREP) Act declarations, continuing PREP Act coverage for pandemic influenza, Ebola virus disease vaccines and therapeutics, anthrax, botulinum toxin, smallpox, and Acute Radiation Syndrome medical countermeasures. Also see PREP Act FAQs.
  • FDA issued a PAHPRA question and answer document (PDF, 762 KB) in 2014 to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies
  • View more information and all current EUAs on our Emergency Use Authorization page, or view the EUA archive for EUAs that are no longer in effect
     

  • April 15, 2016: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies. DuoDote, AtroPen, CANA, Morphine Sulfate, and Pralidoxime Chloride auto-injectors manufactured by Meridian Medical Technologies nearing or beyond their labeled or extended expiration dates should be retained until further guidance is provided by FDA. More about expiration dating extensions

  • February 1, 2016: FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding drug shortages. Read more in the FDA Voice blog.

  • September 15, 2015: Expiry date extensions of certain lots of doxycycline hyclate 100mg capsules held in strategic stockpiles (PDF, 28 KB) - memo to state and local public health and first responder stakeholders - related: doxycycline and penicillin G procaine for inhalational anthrax (post-exposure)
  • August 11, 2015: The Drug Shortages 2 app disclaimer icon is now available for Android devices on Google Play. Drug Shortages 2 includes an Alerts feature. You can opt in to receive notifications on your mobile device when FDA adds or updates shortage information about a drug product or one or more drugs within a selected therapeutic category. First launched March 4, 2015, the app identifies current drug shortages, resolved shortages and discontinuations of drug products. FDA is currently working on notifications for the iOS version of the mobile app. The app for Apple devices disclaimer icon is available for free download via iTunes.
  • July 8, 2015: FDA is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
  • April 2015: FDA has posted a new drug shortages infographic
  • For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database  
 

 

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Page Last Updated: 08/26/2016
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