Ebola response updates from FDA - updates related to the Ebola epidemic, including fast facts, statements, outbreak-related contact information, frequently requested links, information on FDA's role, Emergency Use Authorization, and more. - Español - Français
December 16, 2014: FDA approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections.
December 12, 2014: Public workshop: Immunology of Protection from Ebola Virus Infection (Rockville, MD and webcast) - The purpose of this workshop was to discuss important aspects of Ebola virus and vaccine immunology in order to inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola. Webcast recordingnow available
December 12, 2014: HHS blog by Secretary Burwell - A Timely Recognition (on "The Ebola Fighters" as Time Magazine Person of the Year)
December 8, 2014: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations and implications of public health emergency response, with a focus on the current Ebola virus disease epidemic. Comments due February 6, 2015.
November 26, 2014: At the manufacturer's request, FDA reissued Emergency Use Authorization of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. More (also see Emergency Use Authorization below)
November 26, 2014: In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued (PDF, 263 KB) the November 10, 2014 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The Instructions for Use (PDF, 634 KB) and Fact Sheet for Health Care Providers (PDF, 81 KB) have also been updated to incorporate these amendments. more
November 10, 2014: (see note above about update on Novembr 26, 2014) FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. The test, which does not distinguish between different Ebola virus species or strains, detects Ebola viruses in plasma from individuals with signs and symptoms of Ebola virus infection, in conjunction with epidemiological risk factors. Under this authorization, the test must be conducted on specified instruments by CLIA high complexity laboratories. This EUA provides another commercial Ebola diagnostic (in addition to the October 25, 2014 EUA for the BioFire Defense FilmArray Biothreat-E test). Note: Documents issued on November 10, 2014 are now archived.
October 25, 2014: FDA authorized emergency use of two BioFire Defense diagnostic tests to detect the Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection, or who are at risk for exposure, or may have been exposed (in conjunction with epidemiological risk factors). The BioFire Defense FilmArray NGDS BT-E Assay is for use by laboratories designated by the Department of Defense (DoD). The BioFire Defense FilmArray Biothreat-E test is for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests. The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab. more
October 10, 2014: FDA authorized emergency use of two Centers for Disease Control and Prevention (CDC) diagnostic tests to detect the Ebola Zaire virus in individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay can test for the virus in whole blood, serum, and plasma specimens, and can also be used with urine specimens when tested in conjunction with whole blood, serum, or plasma from the same patient. Use of these tests is limited to qualified laboratories designated by the CDC. more
October 10, 2014: Upon request from the U.S. Department of Defense (DoD), FDA has reissued the August 5, 2014 Emergency Use Authorization (EUA) for use of a DoD diagnostic test to detect the Ebola Zaire virus. The test is designed for use in individuals, including DoD personnel, who may be at risk of infection as a result of the outbreak. The reissued EUA replaces the August 5, 2014 EUA. The EUA has been amended to expand the types of specimens that can be tested to include whole blood and plasma, in addition to blood or plasma that has been treated to make the sample non-infectious. The August 5 letter of authorization, fact sheets, and instructions for use have all been reissued to reflect this amendment. more
August 5, 2014:(see note above about update on October 10, 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, 2014Federal Register notice - HHS Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola; September 17, 2014 Federal Register notice - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus)
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.
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
December 18, 2014: Proposed rule - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - FDA is proposing to amend prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed, to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs. Submit comments by March 18, 2015.
November 24, 2014: FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA-approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. Submit comments by January 23, 2015. (Federal Register notice)
November 21, 2014: Clinical Trials Registration and Results Submission (Federal Register notice) - HHS is seeking input on a proposed rule to update how data that were collected and analyzed in accordance with a clinical trial's protocol are to be submitted to ClinicalTrials.gov. Read a news release and summary of changes from NIH. Comments are due by February 19, 2015.
October 29, 2014: Request for comments: Best Practices for Communication Between the Food and Drug Administration and Investigational New Drug Sponsors During Drug Development - comments due December 29, 2014
October 16, 2014: FDA updates on saline drug shortage - In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline), B. Braun Medical Inc. of Bethlehem, Pa., will temporarily distribute normal saline in the United States from its manufacturing facility in Germany. FDA is temporarily exercising its discretion regarding the distribution of B. Braun’s saline product from Germany, in addition to Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway, to help address this critical shortage, which poses a serious threat to patients. more