miércoles, 20 de junio de 2018

Zika virus research update | FDA statements on biopreparedness

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
A scientist works in the lab at the UC Davis California National Primate Research Center. (Image courtesy of CNRPC)

New research studies Zika virus transmission 
FDA-supported study informs medical countermeasure development
To develop effective medical countermeasures (MCMs) to treat and protect against emerging threats, including the Zika virus, the scientific community must first learn more about how the pathogen (in this case, virus) infects the human body, and how it affects infected patients, including potential donors of transplantable cells, tissues, or organs.

Despite presenting as a mild illness in most patients, Zika has broader public health implications, including its potential impact on developing fetuses when pregnant women become infected. To learn more about how Zika virus impacts a variety of tissues and organs in the developing fetus, FDA partially funded a research project by the University of California, Davis (UCD).

As outlined in a publication today in the journal Nature Communications, this work is a step toward development of a relevant model of fetal Zika virus neurologic disease, providing proof-of-concept information on factors that determine the severity of disease and the efficacy of interventions to guide clinical trials for Zika medical countermeasures, and informing FDA regulatory activities.
Image: A scientist works in the lab at the UC Davis California National Primate Research Center. (Image courtesy of CNRPC, via video
FDA statements on biopreparedness
Recent remarks from FDA officials testifying before the U.S. House of Representatives, Committee on Energy and Commerce:
Events
Information for industry
More: MCM-Related Guidance by Date
In case you missed it
  • MCMi Fiscal Year 2017 Program Update - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. 
  • FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens - FDA filed a complaint against Innovative BioDefense, Inc. of Lake Forest, California, and Colette Cozean, the company’s president and chief executive officer, to prohibit them from selling Zylast topical antiseptics with claims that they are effective against infection by pathogens such as norovirus, rotavirus, flu virus, Methicillin-ResistantStaphylococcus aureus (MRSA), and Ebola. Claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs. These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA. (June 6, 2018) 
MCMi FY 2017 program update report cover

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