Biologics License Application

Biologics License Application (BLA) is a request submitted to the Food and Drug Administration (FDA) for permission to introduce, or deliver for introduction, a Biologic product into interstate commerce. The pronunciation is /baɪˈɒlɪdʒɪks ˈlaɪsəns æplɪˈkeɪʃən/.

Etymology

The term "Biologics License Application" is derived from the English language. "Biologics" refers to products that are derived from living organisms, "License" refers to the permission granted by the regulatory authority, and "Application" refers to the act of putting something into operation.

Related Terms

• Biologic product
• Food and Drug Administration
• Interstate commerce
• Regulatory authority

See Also

• Investigational New Drug
• New Drug Application

References

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