viernes, 19 de mayo de 2017

Medical countermeasure research at FDA Science Forum | New June events

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May 19, 2017  |  FDA Medical Countermeasures Initiative Update

MCM research at FDA Science Forum

Learn about FDA's medical countermeasure (MCM)-related research, and discover how you can collaborate with FDA. Sessions of interest to MCM stakeholders include:
  • Use of an FDA Real-time Mobile Communication Platform System during Medical Countermeasure Events: RAPID - Henry "Skip" Francis, MD, Director for Data Mining and Informatics Evaluation and Research,  FDA Center for Drug Evaluation and Research (CDER)
  • Development of Total and Neutralizing Anti-Ebola Virus Antibody Assays for Deployment in West Africa to Evaluate Clinical Trials of MCMs, including Vaccines and Immunotherapies - Geraldo Kaplan, PhD, Principal Investigator, Center for Biologics Evaluation and Research (CBER)
  • Development of Mouse Models to Assess Efficacy and Potency of Zika Virus - Daniela Verthelyi, MD, PhD, Lab Chief, CDER
  • FDA-ARGOS Microbial Reference Genomes for Regulatory use: Zika and Ebola - Heike Sichtig, PhD, SME, Principal Investigator, Center for Devices and Radiological Health (CDRH) - more about FDA-ARGOS
  • Nanomaterial-Based In Vitro Diagnostics for Pathogens - Indira Hewlett, PhD, Laboratory Chief, CBER
Related information

EUA updates

Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at, in addition to reporting concerns to the manufacturer.
  • May 10, 2017: The HHS Secretary issued a PREP Act Declaration under the Public Readiness and Emergency Preparedness Act to provide liability protections related to medical countermeasures against nerve agents and certain insecticides (organophosphorus and/or carbamate). The declaration was published in the Federal Register on May 10, 2017, with an effective date of April 11, 2017.
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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