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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

 

  • August 25, 2014 – FDA and the World Health Organization Department of Essential Medicines and Health Products (WHO EMP) have signed an agreement (PDF, 550 KB)  to help facilitate communications between FDA and WHO EMP regarding an actual or potential public health crisis or public health emergency of international concern, such as the Ebola outbreak in West Africa. The agreement allows sharing of information that is non-public but important to address public health emergencies between the organizations. More information about FDA’s international arrangements

  • August 22, 2014: FDA Voice blog post: FDA works to mitigate the West Africa Ebola outbreak - The world is witnessing the devastating effects of the Ebola virus outbreak in West Africa, the worst Ebola outbreak in recorded history. We at FDA are dedicated to helping end this outbreak as quickly as possible, and to help prevent future outbreaks like this. Read more

  • August 22, 2014: FDA has a new web page dedicated to the 2014 Ebola outbreak in West Africa, where we will post FDA updates related to this outbreak, including "fast facts," statements, outbreak-related contact information, frequently requested links, and information on FDA's role, Emergency Use Authorization, and more. - Español - Français

  • August 20, 2014: Responding to Ebola: The View From the FDA disclaimer icon - As part of FDA's expert commentary and interview series, Medscape spoke with FDA Acting Deputy Chief Scientist and Assistant Commissioner for Counterterrorism Policy Luciana Borio, MD.  

  • August 15, 2014: MCMi email update - September events, and presentations from antimicrobial resistance workshop disclaimer icon - subscribe to these updates disclaimer icon

  • August 15, 2014: For healthcare professionals who administer inactived influenza vaccines - FDA Updated Communication on Use of Jet Injectors with Inactivated Influenza Vaccines

  • August 14, 2014: FDA statement - FDA is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

  • August 6, 2014: FDA news release - FDA approves Orbactiv to treat skin infections - Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI.

  • August 1, 2014: HHS news release - New committee will advise HHS on children’s health in disasters disclaimer icon

  • July 30-31, 2014 presentations from NIH/FDA workshop: The Development of New Antibacterial Products: Charting a Course for the Future - Day 1 presentations disclaimer icon, Day 2 presentations disclaimer icon

  • 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 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.

  • 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.

  • Influenza Virus Vaccine for the 2014-2015 Season

  • For more MCMi news, visit our News Archive page 

     

  • August 5, 2014: Emergency Use Authorization for DoD EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus - FDA has authorized the use of an in vitro diagnostic test developed by the U.S. Department of Defense (DoD) to detect the Ebola Zaire virus. The agency has authorized its use in laboratories designated by DoD to help facilitate effective response to the ongoing Ebola outbreak in West Africa. (Related: August 12, 2014 Federal Register notice disclaimer icon - HHS Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola) 

  • 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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