miércoles, 15 de agosto de 2018

Regulatory science research tools

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

An FDA scientist divides plasma from individuals recently infected with dengue or  West Nile viruses into smaller volume samples for distribution. 
Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile). (FDA photo)

Regulatory science research tools
Helping researchers advance medical countermeasure (MCM) development 
The FDA Medical Countermeasures Initiative (MCMi) funds research to further MCM development, including building tools to help MCM researchers advance their products and help FDA reviewers evaluate MCM products for approval.

MCM-related regulatory science tools funded (or partially funded) by FDA include:
  • Cross-species immune system reference
  • FDA-ARGOS (FDA dAtabase for Regulatory Grade micrObial Sequences)
  • Zika virus reference materials for diagnostic developers
  • FDA-CDC Antimicrobial Resistance Isolate Bank
Learn more about these tools, including how you can access them for your MCM-related research.

Image: An FDA scientist divides plasma from individuals recently infected with dengue or West Nile viruses into smaller volume samples for distribution. Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile). (FDA photo)
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