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September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.
“This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.
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