sábado, 27 de febrero de 2016

Zika response updates from FDA, including an Emergency Use Authorization issued today

FDA Medical Countermeasures 

Initiative Update

New Emergency Use Authorization

Zika Virus

A pregnant woman applies mosquito repellant (CDC)
On February 26, 2016, FDA issued an Emergency Use Authorization (EUA) to authorize 
the use of the CDC’s Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked 
Immunosorbent Assay (MAC-ELISA) test for the detection of Zika virus antibodies in 
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). 
The CDC and FDA have been working closely together as CDC obtained necessary 
performance data that was then reviewed by FDA in order to authorize the emergency 
use of this in vitrodiagnostic test for the detection of antibodies to Zika virus.
 More about this EUA 

Related information

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; this will also protect her unborn baby from the virus. (Credit: CDC/Division of Vector-borne Diseases)

Zika Virus in the Americas: An HHS Expert Consultation to Accelerate the Development of Countermeasures

March 28-29, 2016

 Rockville, MD
The workshop will review current information about the virus’ epidemiology (including potential link to microcephaly), and clinical manifestations and pathogenesis of Zika virus. There will also be discussion of strategies to accelerate the development of vaccines, diagnostics, therapeutics and novel vector control methods and ensure blood supply safety.
This consultation is supported by NIAID, NICHD, ASPR/BARDA, CDC and FDA within the U.S. Department of Health and Human Services.

FDA issues recommendations to reduce the risk for Zika virus blood transmission in the United States

As a safety measure against the emerging Zika virus outbreak, FDA issued a new guidance (PDF, 111 KB) recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.

News updates

More events:
  • New series! March 10, 2016: FDA Grand Rounds - The Host Response to Pertussis Infection and Vaccination (webcast), presented by Tod Merkel, PhD, Principal Investigator in FDA's Center for Biologics Evaluation and Research (CBER). The 45-minute presentation is followed by questions from the audience.
View more events on the frequently updated MCMi News and Events page
Guidance and information for industry:
  • FDA is announcing the availability of a draft guidance for industry Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (PDF, 565 KB). The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled “Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs” issued in March 2002. Comment by April 18, 2016. (Federal Register notice(February 16, 2016)
  • FDA announced that influenza virus neuramindase (NA) is available for licensing. This technology may offer an alternative to currently available therapeutic NA inhibitors. Potential commercial applications include: prophylactic and therapeutic against influenza virus infections; diagnostic tests for influenza virus infections; and reagent to measure the potency of H1N1 NA in influenza virus vaccines. (February 12, 2016)
Funding opportunities and other deadline reminders:
  • FDA calls on the genomics community to further assess, compare, and improve techniques used in DNA testing by launching the first PrecisionFDA challenge. The challenge is open through April 25, 2016.
In case you missed it:
  • Meeting videos are available for the February 16, 2016 Institute of Medicine workshop Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus. Presentations are also available, under Other Meeting Resources, on the right side of the videos page.

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