New Emergency Use Authorizations - Ebola and MERS-CoV

FDA Medical Countermeasures Initiative Update

Emergency Use Authorizations

Ebola

On 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

MERS-CoV

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). more

Related information

• View current diagnostic EUAs, including Ebola and MERS-CoV
• More about EUAs, and list of all current EUAs (all product types)
• How the EUA process works (graphic)
• Ebola response updates from FDA: view the main page, or updates by date

Image: Ebola treatment center in West Africa, taken in July 2014 (Credit: CDC/Flickr). More aboutCDC's Ebola response efforts.

News updates

Events:

• August 24, 2015: Quality Metrics Public Meeting - The public meeting and draft guidance(PDF, 250 KB) are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry.  Register by August 7, 2015. Read an FDA Voice blog post about Quality Metrics.

• September 15, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. (Federal Register notice)

• September 18, 2015: 2015 FDA Science Writers Symposium - a special event intended to engage and inform science and health journalists about how the FDA is applying scientific approaches to critical public health issues. Registration is free and open to credentialed media; register by September 14, 2015.

• September 28, 2015: FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data (Silver Spring, MD and webcast) - The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. Register by September 18, 2015.

• September 29-30, 2015: Public workshop - Medical Device Patient Labeling (Silver Spring, MD and webcast) - register to attend in person or online by September 21, 2015

View more events on the frequently updated MCMi News and Events page

Preparedness and response: 

• HHS awards improve health care, public health preparedness - Health departments across the country will receive more than $840 million in cooperative agreements from the U.S. Department of Health and Human Services to improve and sustain emergency preparedness of state and local public health and health care systems. (July 6, 2015)

• HHS has published a Response and Recovery Resources Compendium, a comprehensive web-based repository of HHS resources and capabilities available to Federal, State, local, territorial and tribal stakeholders before, during, and after public health and medical incidents. (July 15, 2015)

• The White House published a fact sheet on the Global Health Security Agenda. (July 28, 2015)

Ebola: 

• HHS launches National Ebola Training and Education Center - three hospitals funded to train, prepare other U.S. health care facilities for Ebola and emerging threats (July 1, 2015)

• HHS partnership advances experimental Ebola drug - Department calls on Centers for Innovation in Advanced Development and Manufacturing (July 20, 2015)

• CDC report - The Road to Zero: CDC's Response to the West African Ebola Epidemic, 2014-2015 (July 2015)

Federally funded research:

• Read about an FDA MCMi intramural project: Biomarkers for Brain Injury Monitoring (July 2015)

Image: FDA scientist Anjuli Jain conducts an experiment validating nonclinical biomarker models for traumatic brain injury. This research will potentially help establish a regulatory pathway for the use of emerging flexible EEG technologies to rapidly detect brain injury during emergency response situations, such as explosions. (Photo: FDA staff)

• Read a new report to the FDA Science Board, Science Moving Forward (PDF, 1.4 MB), or scan the highlights on the FDA Voice blog (July 29, 2015)

• NIH/NIAID research news - Virus-Like Particle Vaccine Protects Mice from Many Flu Strains (July 21, 2015)

• NIH/NIAID research news - Experimental MERS Vaccine Shows Promise in Animal Studies(July 28, 2015)

Guidance:

• Draft Guidance - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (PDF, 355 KB) - comment by August 31, 2015 (Federal Register notice) - read more about medical gowns  (June 26, 2015)

• Drug Supply Chain Security Act (DCSA) Implementation: Product Tracing Requirements for Dispensers—Compliance Policy (PDF, 58 KB) (July 6, 2015)

• Final Guidance - Meetings with the Office of Orphan Products Development (PDF, 94 KB) - This guidance provides recommendations to industry, researchers, patient groups, and other stakeholders interested in requesting a meeting with FDA's Office of Orphan Products Development (OOPD) on issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. (Federal Register notice) (July 9, 2015)

• Guidance for Industry - Analytical Procedures and Methods Validation for Drugs and Biologics (PDF, 134 KB) (Federal Register notice) (July 27, 2015)

Also see Request for Quality Metrics, under Events above

Deadline reminders:

• NIAID is seeking development of therapeutic products for use in post-event settings following the release of a NIAID Category A, B, or C Priority Pathogen, or in response to naturally occurring outbreaks of infectious diseases caused by these pathogens. Responses are due August 31, 2015.

• CDC is proposing to add certain H5N1 influenza virus strains to the list of HHS select agents and toxins. Comment by September 14, 2015.

• NIH and CDC are soliciting proposals from small businesses to conduct research and development, including possible medical countermeasure-related research - respond byOctober 16, 2015. 

• FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects

In case you missed it:

• FDA Voice video blog - FDA Science Forum 2015: Views of FDA (July 21, 2015)

• FDA is amending its regulations to implement certain drug shortages provisions of 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. (July 8, 2015)

• MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB) (June 2015)

• FDA white paper - Targeted Drug Development: Why Are Many Diseases Lagging Behind? (July 2015)

• Innovation at FDA - These updated web pages outline how FDA is helping to speed treatments and cures to patients. The new section includes news, blog posts, speeches, fact sheets, and reports. (July 2015)