Biologic license application

From Infogalactic: the planetary knowledge core
Jump to: navigation, search

A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

  • Applicant information
  • Product/Manufacturing information
  • Pre-clinical studies
  • Clinical studies
  • Labeling

Reference: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/

Biological product vs. biologic vs. biologics

Throughout the FDA web site,[1] literature,[2] and Wikipedia,[3] the following variations of the term are used.

  • Biologics license application
  • Biologic license application
  • Biological license application
  • Biological product license application

Per 21 CFR 601, the official term utilized is "biologics license application."

This article uses the word "biologic" for the following reasons:

  1. It is the more common shorter form used for the expression "biological product".
  2. "Biological product license application" has regulatory weight because it is used in the Federal Register,[4] but it is seldom used anywhere else.
  3. Nouns used as modifiers in compound nouns are not traditionally considered grammatically correct in the plural (e.g. "two-car garage") unless the singular would have a different meaning (e.g. "arms race").
  4. It is the term used in the heading of the FDA's glossary entry[5] (although within the entry, it uses "biologics" — see the quoted definition above.)
  5. It is the term used on the actual form, which is titled "APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE"[6]

See also

References

  1. ↑ FDA web site search results for "Biologic License Application". Accessed 07 July 2010.
  2. ↑ Google search results for "Biologic License Application". Accessed 07 July 2010.
  3. ↑ Wikipedia web site search results for "Biologic License". Accessed 07 July 2010.
  4. ↑ Federal Register (Vol. 62, No. 16, Friday, January 24, 1997), pp. 3703-3704.
  5. ↑ FDA: Drugs@FDA Glossary of Terms, "Biologic License Application (BLA)". Accessed 07 July 2010.
  6. ↑ FDA: FORM FDA 356h (10/05), "APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE". Accessed 07 July 2010.
Retrieved from "https://infogalactic.com/w/index.php?title=Biologic_license_application&oldid=719735365"