viernes, 18 de noviembre de 2016

FDA research to help speed development of Zika virus vaccines and therapeutics

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November 17, 2016  |  FDA Medical Countermeasures Initiative Update

The FDA's regulatory science research program is an essential component of the national response to emerging infectious diseases.


FDA research to help speed development of Zika virus vaccines and therapeutics

Neonatal mouse model provides a new platform for Zika virus research
A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLOS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus.
"There are many unanswered and essential questions about how the Zika virus works, including the long-term impact," said Daniela Verthelyi, MD, PhD, FDA’s Chief of the Laboratory of Immunology, who led the agency's development of the new animal model. "This mouse model gives researchers a new tool to study and understand how the Zika virus replicates and spreads in the body, which we hope will provide these critical answers." 
Related Information

Extramural research spotlight: 

How to Steward Medical Countermeasures and Public Trust in an Emergency
Broadly distributing meaningful and timely risk and benefit information concerning medical countermeasures (MCMs) in an emergency is essential to increasing voluntary and proper use of recommended countermeasures, and ultimately improving public health outcomes—saving lives.
An extramural research project conducted by the UPMC Center for Health Security sought to better prepare public health communicators to get MCM risk and benefit information to the public how and when they need it.
The views, opinions, and/or findings contained in this report are those of the authors and not necessarily those of the FDA.
How to Steward Medical Countermeasures and Public Trust in an Emergency - casebook by UPMC CHS

EUA Updates

On November 15, 2016, in response to CDC's request, FDA concurred(PDF, 155 KB) with the modification to the CDC algorithm for results confirmation of the Zika MAC-ELISA as outlined in the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection(revised). The Instructions for Use and Fact Sheets remain unchanged by this request. Additional technical information - also see from CDC: Updated Laboratory Guidance - Frequently Asked Questions
On November 3, 2016, FDA amended and reissued (PDF, 529 KB) the Ebola virus diagnostic EUA initially authorized on February 24, 2015, to transfer ownership of the ReEBOV™ Antigen Rapid Test EUA from Corgenix Inc. to Zalgen Labs, LLC.  Additional technical information
On October 31, 2016, in response to altona Diagnostics GmbH's request, FDA concurred (PDF, 129 KB) with the revision to add the MagNA Pure 96 Instrument (Roche) and the NucliSENS® easyMAG® Instrument (bioMérieux) and their respective extraction chemistry/reagents as authorized extraction methods under the EUA of the RealStar® Zika Virus RT-PCR Kit U.S. issued on May 13, 2016. Additional technical information
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Guidance and information for industry

  • FDA is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. To ensure that the Agency considers your comments in this review, submit comments by January 9, 2017.Also see the Pharmaceutical Users Software Exchange (PhUSE) SDSP template(PDF, 74 KB) (November 8, 2016)

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