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Biologics Electronic Reading Room (eFOIA)
… Conferences (Biologics) FDA Forms FDA Newsroom AstraZeneca COVID-19 Vaccine IND Related Records AstraZeneca COVID-19 Vaccine IND Related Records Moderna Tx, Inc SPIKEVAX …
Biologics PREA Reviews and Labeling Changes
… Review Statistical Review Artiss Fibrin Sealant (Human) 3/19/2008 Package Insert Statistical Review and Evaluation … Review and Evaluation Clinical Review Memo COMIRNATY COVID-19 Vaccine, mRNA 9/11/2023 Package Insert Clinical … Package Insert Clinical Review Statistical Review SPIKEVAX COVID-19 Vaccine, mRNA 9/11/2023 Package Insert Clinical …