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FDA Issues Guidance on EUA for COVID-19 Vaccines

Provides further information on the EUA process for investigational vaccines.

By: Contract Pharma

Contract Pharma Staff

On October 6, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.   The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regu...

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