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Experts: COVID-19 Booster Shots Will Raise Approval, Labeling Questions

By Beth Wang / June 9, 2021 at 3:11 PM
Regulatory experts say the development of booster vaccines for COVID-19 raises key regulatory and approval questions for FDA, namely whether the booster shots will be considered wholly new products and have to go through the standard biologics testing and approval process, and whether booster shots from one manufacturer can be mixed and matched with original vaccine regimens from another manufacturer. One of the experts says FDA should consider how to expedite development of booster shots so they can get to...


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