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CLINICAL REVIEW Application Type Application Number(s) Priority or Standard BLA supplement 125289/133 StandardSubmit Date(s) Received Date(s) PD UFA Goal Date Division / Office August 22, 2016, August

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What is bla supplement?

Bla supplement is a submission that is filed by a pharmaceutical company to the FDA in order to request changes to an approved biologics license.

Who is required to file bla supplement?

Any pharmaceutical company that holds an approved biologics license is required to file a bla supplement when requesting changes to the original approval.

How to fill out bla supplement?

Bla supplements can be filled out electronically using the FDA's Electronic Submissions Gateway (ESG) or manually by submitting a paper application.

What is the purpose of bla supplement?

The purpose of a bla supplement is to request changes to an approved biologics license, such as adding new indications, changing manufacturing processes, or updating labeling.

What information must be reported on bla supplement?

Bla supplements must include detailed information about the proposed changes, supporting data, and any potential risks or benefits associated with the changes.