Biologics License Application (BLA)
BLAA 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.
例
- 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.