FDA Medical Countermeasures Initiative Update

Zika virus response updates from FDA (English)

Actualizaciones de la respuesta de la FDA al virus del Zika (Spanish)

Atualizações de resposta vírus Zika do FDA (Portuguese)

Related information

Zika virus diagnostic development
Creación de pruebas de diagnóstico para el virus del Zika (Zika virus diagnostic development - Spanish)
Desenvolvimento de diagnóstico dp vírus Zika (Zika virus diagnostic development - Portuguese)
Actualizaciones de virus Zika CDC en Español (CDC Zika virus updates in Spanish)
Atualizações de vírus CDC Zika em Português (CDC Zika virus updates in Portuguese)

Image: A pregnant woman applies mosquito repellant. Using insect repellants will help to protect her from being bitten by a mosquito that may be carrying a virus such as Zika. (Image: CDC/Division of Vector-borne Diseases)

New Zika Diagnostic Emergency Use Authorization (EUA)

On May 13, 2016, FDA authorized emergency use of the altona Diagnostics GmbH RealStar Zika Virus RT-PCR Kit U.S. 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 active Zika virus transmission. This test is intended for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests.

This is the first commercial Zika diagnostic test that will be available for purchase by labs and will include serum and urine specimens.

Related information

News updates

Events:

May 17-19, 2016: 14th Annual Vaccines & Therapeutics - Biodefense, Antimicrobial Resistance, Emerging Infectious Diseases , hosted by Infocast (Washington, DC) - FDA representatives will present (fee)

June 1, 2016: Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics (Silver Spring, MD, and webcast), jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and FDA -registration required (fee, for some in-person participants)

New! June 30, 2016: Public Workshop - Clinical Trial Design Considerations and Laboratory Testing Technologies for Malaria Drug Development (Silver Spring, MD) (Federal Register notice)

July 18-19, 2016: Medical Management of Radiation Casualties: Where Research and Usage Meet (Rockville, MD), hosted by the Radiation Injury Treatment Network and the National Institute of Allergy and Infectious Diseases (NIAID)

New! September 8, 2016: Public Workshop - Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (Silver Spring, MD and webcast) - advance registration required for all attendees

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

Guidance and information for industry:

Draft Guidance - Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers(PDF, 1.4 MB) - comment by August 11, 2016

Draft Guidance - Technical Considerations for Additive Manufactured Devices (PDF, 548 KB) - This draft guidance provides FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3D printing. Comment by August 8, 2016. More about 3D printing of medical devices

Draft Guidance - Special Protocol Assessment (PDF, 640 KB) - SPA is a process in which sponsors may request to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal trials to determine if they adequately address scientific and regulatory requirements. This draft guidance revises the guidance for industry Special Protocol Assessment issued in May 2002. After it has been finalized, this guidance will replace the May 2002 guidance. Significant changes from the 2002 version include: clarifying which protocols are eligible for SPA; adding animal rule efficacy protocolsintended to support approval under 21 CFR part 314, subpart I, and 21 CFR part 601, subpart H, for drugs and biological products, respectively; adding protocols intended to support approval of a biosimilar biological product; providing greater detail about the content of an SPA submission; and clarifying the process for rescinding an SPA agreement. (May 3, 2016)

Draft Guidance - Emergency Use Authorization of Medical Products and Related Authorities(Federal Register notice) - comment by June 3, 2016

How to submit comments

In case you missed it:

In direct response to requests from the public, FDA has extended the comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes. Aedes aegypti mosquitoes are known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. The comment period ends today, May 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. Theemergency 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 13, 2016)

HHS-sponsored study shows disrobing is vital decontamination method - Study provides new scientific evidence of best methods to protect people from chemical contamination - also seeDecontamination Guidance for Chemical Incidents, from HHS (May 10, 2016)

FDA issues rule for data collection of antimicrobial sales and distribution by animal species - Additional data help further target efforts to ensure judicious use of medically important antimicrobials (Federal Register notice) - additional information from FDA's Center for Veterinary Medicine (May 10, 2016)

From CDC's Public Health Matters Blog - The Strategic National Stockpile’s Unique Role in Zika Prevention (May 9, 2016)

Presentations and transcripts are now available from the Filovirus Medical Countermeasures Workshop held at Fort Detrick, MD in October 2015 (May 2, 2016)