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Clerk of the House of Representatives Legislative Resource Center B106 Cannon Building Washington, DC 20515 Secretary of the Senate Office of Public Records 232 Hart Building Washington, DC 20510
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What is biogen?
Biogen stands for Biological License Application (BLA) information. It is a form required by regulatory authorities for the licensing of certain biological products.
Who is required to file biogen?
Biotechnology companies and manufacturers of biological products are required to file biogen.
How to fill out biogen?
Biogen 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 biogen?
The purpose of biogen is to provide regulatory authorities with information about the safety, efficacy, and quality of biological products.
What information must be reported on biogen?
Information about the manufacturing process, clinical trials, labeling, and packaging of biological products must be reported on biogen.
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