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.
示例
- 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.