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.

  • 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  • April 1, 2016: Draft Guidance - Emergency Use Authorization of Medical Products and Related Authorities (Federal Register notice) - comment by June 3, 2016
  • March 17, 2016: FDA issued an EUA to authorize the emergency use of the CDC’s Trioplex rRT-PCR, a laboratory test designed to detect Zika virus and two other viruses (dengue and chikungunya) also spread by mosquito bites. Additional technical information - also see the FDA Zika response page and the CDC statement

  • March 4, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals. Additional technical information
  • March 2, 2016: Determination and declaration regarding emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection - more Zika virus EUA information
  • February 26, 2016: FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use by qualified laboratories of Centers for Disease Control and Prevention's (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA)  for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside a patient-matched serum specimen from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health response). New: fact sheets now available in Spanish (hojas informativas ahora en español : Nuevo) More - also see the FDA Zika response page and the CDC statement for additional information 
  • February 16, 2016: On July 17, 2015, FDA issued an EUA to authorize the emergency use of the RealStar® MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors for the presumptive detection of MERS-CoV, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and similarly qualified non-U.S. laboratories.

    In response to altona Diagnostics GmbH's request to amend this EUA, on February 12, 2016 FDA reissued the July 17, 2015 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments authorize the expanded use of the RealStar® MERS-CoV RT-PCR Kit U.S. to include the in vitro qualitative detection of genomic RNA from MERS-CoV in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-Co V cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated). The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases (PDF, 285 KB) and revisions to the Instructions for Use (PDF, 840 KB), and fact sheets for health care providers (PDF, 269 KB) and patients (PDF, 241 KB).
  • December 9, 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: 05/02/2016
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