Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry | NLM

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Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry

10/06/2020 12:00 AM EDT

Source: U.S. Food and Drug Administration (FDA). Published: 10/6/2020. The Food and Drug Administration (FDA) has issued this 18-page guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency. (PDF)