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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCMi News and Events

Medical countermeasure photo montage with scientist in lab, flu virus particle (magnified), gloved hands administering vaccine, pill bottles

News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners

 

  • July 21, 2014: DARPA is soliciting proposals disclaimer icon for research supporting the potential use of Bdellovibrio and/or Micavibrio bacterial predators as therapeutics against infections caused by Gram-negative antibiotic-resistant and priority threat pathogens. BAA responses due September 23, 2014.
  • July 2014: Funding Opportunity Announcements - NIAID is soliciting applications disclaimer icon for those interested in joining the Centers for Medical Countermeasures Against Radiation Consortium; letters of Intent due September 3, 2014. Development of Novel Therapeutics for Select Pathogens disclaimer icon (NIAID). Letters of intent due September 19, 2014.
  • June 20, 2014: FDA news release - FDA approveds Sivextro to treat skin infections - FDA today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat ABSSSI.
  • June 18, 2014: NIAID seeking proposals - The Radiation and Nuclear Countermeasures Program seeks proposals for multidisciplinary basic and translational research disclaimer icon to support the development of new medical products that will assess, diagnose, mitigate and/or treat the short- and long-term consequences of radiation exposure after a radiological/nuclear terrorist event or accidental exposure. Submissions due October 3, 2014.
  • June 17, 2014: HHS Statement - "This week, our nation reached a milestone in battling influenza, with the U.S. Food and Drug Administration’s first approval to manufacture seasonal influenza vaccine using cell-based technology in a U.S. facility. That facility, owned by Novartis of Basel, Switzerland, and located in Holly Springs, N.C., now can manufacture cell-based vaccine against seasonal as well as pandemic influenza viruses. This new capability demonstrates the effectiveness of a multi-use approach to emergency preparedness."  Read the full statement
  • HHS Assistant Secretary for Preparedness and Response (ASPR) blog series: Combatting Antibiotic Resistance - This series is designed to highlight the antibiotic resistance crisis and some of the actions that are being taken to mitigate the threat.
  • June 2, 2014: FDA News Release - FDA launches openFDA to provide easy access to valuable FDA public data - openFDA site
  • For more MCMi news, visit our News Archive page 
  • June  10, 2014: Emergency Use Authorization (Potential Emergency) for CDC IVD for MERS-CoV -
    In response to CDC’s request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013 EUA in its entirety with the CDC-requested amendments incorporated.  The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors. The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals. This device will be distributed by CDC to qualified laboratories.
  • April 25, 2014: Emergency Use Authorization (Potential Emergency) for Arbor Vita Corporation IVD for H7N9 Influenza
  • February 14, 2014: Emergency Use Authorization (Potential Emergency) for Quidel IVD for H7N9 Influenza (Federal Register notice disclaimer icon)
  • January 2, 2014: FDA issued a PAHPRA question and answer document (PDF, 762 KB) 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
  • June 5, 2013: FDA issues Emergency Use Authorization (EUA) for CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (replaced - see June 10, 2014 entry above)
  • April 22, 2013: H7N9 Influenza Emergency Use Authorization (Potential Emergency) FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. CDC will distribute this device to public health- and other qualified laboratories.
  • View more information on our Emergency Use Authorizations page
     
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