Biologics License Application (BLA)

BLA

Research

A regulatory submission to the FDA for approval of biological products including monoclonal antibodies, vaccines, and gene therapies. Analogous to the NDA for small molecule drugs.

Beispiele

Adalimumab (Humira) BLA
mRNA vaccines
CAR-T cell therapies

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A regulatory submission to the FDA for approval of biological products including monoclonal antibodies, vaccines, and gene therapies. Analogous to the NDA for small molecule drugs.