miércoles, 31 de mayo de 2017

Help FDA plan for MCM monitoring & assessment in response to public health emergencies

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May 31, 2017  |  FDA Medical Countermeasures Initiative Update

Operations for response, electronic health data, big data, clinical networks

Register by June 1

Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies: A Stand Alone Workshop
June 6-7, 2017  |  Washington, DC
The National Academies of Sciences, Engineering, and Medicine will host a workshop to:
  • Discuss the roles and efforts of the federal government and relevant stakeholders who have an interest in building and maintaining a national medical countermeasure (MCM) monitoring and assessment capability for public health emergencies
  • Discuss federal monitoring and assessment efforts and opportunities for future work in areas including electronic health record capabilities, big data, clinical networks, and operations for response
  • Help inform the development of strategic MCM monitoring and assessment plans for public health emergencies
FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher, MA, BSN, RN, RAC will be the keynote speaker.
All stakeholders with an interest in monitoring the safety and efficacy of MCMs are encouraged to participate.
    Related Information

    FDA Science Forum 2017 - happening now!

    The agenda includes updates on MCM-related research: Zika, Ebola, biomarkers, next-gen sequencing, and more.
    Can't attend in person? View the webcast:
    FDA Science Forum 2017
    EUA Updates
    • May 23, 2017: In response to CDC’s request, FDA issued an EUA amendment (PDF, 28 KB) to (1) authorize additional strengths (i.e., 0.5 mg and 1 mg) of the authorized Rafa Atropine Auto-Injector under the April 11, 2017, EUA and (2) update the authorized EUA Fact Sheets for the authorized Rafa Atropine Auto-Injector to include information about the 0.5 mg and 1 mg strengths. The additional strengths are for pediatric patients weighing 15-40 pounds (0.5 mg) and 41-90 pounds (1.0 mg). The 2 mg strength remains authorized under the EUA for adults and children weighing over 90 pounds. Additional information, including fact sheets
    Zika diagnostic EUA amendment:
    • May 19, 2017: xMAP® MultiFLEX™ Zika RNA Assay (Luminex Corporation) - more info
    Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
    Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated in May 2017.
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