PropertyValue
?:abstract
  • The Emergency Use Authorization (EUA) mechanism is central to the US response to coronavirus disease 2019 (COVID-19). It allows the US Food and Drug Administration (FDA) to respond quickly to novel threats by approving a new drug, device, or diagnostic procedure or expanding off-label use of an existing drug through an accelerated approval process.1 To obtain authorization, evidence must support that a drug or product \'\'may be effective\' to prevent, diagnose, or treat serious or life-threatening diseases or conditions,\' and the known or potential benefits of the product must outweigh known or potential risks.2(p7) The authorization also stipulates that when feasible, a fact sheet is provided to address risks and benefits and make clear that acceptance is voluntary.2 (Am J Public Health. Published online ahead of print November 25, 2020: e1-e4. https://doi.org/10.2105/AJPH.2020.306036).
is ?:annotates of
?:creator
?:doi
  • 10.2105/ajph.2020.306036
?:doi
?:journal
  • American_journal_of_public_health
?:license
  • unk
?:pmid
?:pmid
  • 33237801.0
?:publication_isRelatedTo_Disease
is ?:relation_isRelatedTo_publication of
?:source
  • Medline
?:title
  • Communicating Effectively About Emergency Use Authorization and Vaccines in the COVID-19 Pandemic.
?:type
?:year
  • 2020-11-25

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