Definition

Application to the FDA for permission to introduce a biologic product into interstate commerce. Required for biologics including monoclonal antibodies, vaccines, and gene therapies.

Example

A sponsor submits a BLA for a monoclonal antibody after completing pivotal clinical studies; CBER reviews BLAs for most biologics.

Regulatory source

42 USC 262, 21 CFR 601

Common mistakes

Treating a BLA like an NDA; CMC and manufacturing requirements for biologics are distinct and often more complex.

Inspector question

How do you maintain comparability after manufacturing changes for an approved BLA?

Related terms