martes, 12 de julio de 2016

FDA takes action against Zika virus | HHS Zika diagnostics summit | FDA Grand Rounds on 3D printing + more events

FDA Medical Countermeasures Initiative Update

FDA is rapidly responding to the Zika virus outbreak

FDA Takes Action against Zika Virus

FDA is engaged with our partners across the U.S. Government, the private sector, and the international community—including the World Health Organization and ANVISA (the Brazilian Health Regulatory Agency)—to help minimize the impact of the Zika virus outbreak.

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Image: A female Aedes aegypti mosquito obtains a blood meal from a human host. Photo: James Gathany/CDC

HHS Summit to Accelerate Zika Diagnostics Development

July 15, 2016, Washington, DC and webcast

This summit will cover:
  • Accelerating development of Zika diagnostics for Emergency Use Authorization (EUA) or clearance
  • Facilitating developer access to clinical samples
  • Identifying solutions to improve Zika diagnostic assay sensitivity and specificity
  • Allowing assay developers and reagent creators the opportunity to form collaborations for better Zika diagnostics
In-person registration is full, but web conference participation is still available. Registration is required. 

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FDA Grand Rounds: FDA Research into 3D Printing of its Regulated Products

July 14, 201612:00 - 1:00 p.m. ET

FDA Grand Rounds logo
FDA internal and collaborative research underway seeks to facilitate the innovative development and assessment of innovative products in the additive manufacturing space. This presentation will provide a snapshot of ongoing research efforts internally and in collaboration with FDA’s academic partners.
Topics will include phantoms for device testing, patient-matched devices instrumentation, cleanability assessment, material optimization, and drug printing optimization. 

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News updates

More events:
View more events on the frequently updated MCMi News and Events page
Guidance and information for industry:
In case you missed it:
  • In response to CDC's request to amend the CDC Zika MAC-ELISA EUA, FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments (PDF, 494 KB) incorporated. More (June 26, 2016)

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