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.

  • July 31, 2015: FDA issued an EUA for the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, in laboratories or facilities adequately equipped, trained, and capable of such testing.This point of care test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. more

  • 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). more

  • May 12, 2015: FDA issued an EUA for the CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014. This device will be distributed by CDC to qualified laboratories designated by CDC. more 

  • April 22, 2015: The HHS Secretary issued a PREP Act declaration, effective February 27, 2015, to provide liability protection for activities related to Ebola virus disease therapeutics consistent with the terms of the declaration. (Federal Register notice - about the PREP Act)

  • March 23, 2015: FDA issued an EUA to authorize emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus.The test should be performed in CLIA moderate and high complexity laboratories, or similarly qualified non-U.S. laboratories, by personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems. more

  • March 16, 2015: At the request of the manufacturer, FDA reissued the ReEBOV™ Antigen Rapid Test Emergency Use Authorization, first issued February 24, 2015, to allow distribution by certain authorized distributors. The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments. more

  • March 2, 2015: In response to CDC’s request, FDA reissued the two October 10, 2014 CDC EUAs in their entirety. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument.  The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments (updated attachments).  The amendments also allow the future use of “other authorized instruments,” of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA. more

  • March 2, 2015: In response to BioFire Defense, LLC’s request, FDA reissued (PDF, 326 KB) the October 25, 2014  FilmArray NGDS BT-E Assay EUA in its entirety. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use (PDF, 740 KB) and Fact Sheet for Healthcare Providers (PDF, 40 KB) have also been updated to incorporate this amendment.  The amendments also allow the future use of “other specimen types” when requested by BioFire Defense and concurred with by FDA. more

  • February 27, 2015: Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 - On February 6, 2015, the HHS Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68.

  • 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

  • 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
     

  • 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
  • March 27, 2015: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies - more about expiration dating extensions
  • For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database  

 

 

Page Last Updated: 09/04/2015
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