Biologic License Application

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As defined by the U.S. Food and Drug Administration (FDA), a Biologic License Application (BLA) is:
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics [sic] license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.[1]

Biologic vs. biologics vs. biological

Throughout the FDA web site,[2] literature,[3] and Wikipedia,[4] the following terms have been used:

  • Biologic License Application
  • Biologics License Application
  • Biological License Application
  • Biological Product License Application

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

  1. It is a noun, whereas biological is both an adjective and a noun. For clarity, biologic is preferred.
  2. "Biological Product" License Application has regulatory weight, as it is used in the Federal Register.[5] But as a term, it is seldom used anywhere else.
  3. It is singular, and not plural. Since the application is generally for the licensing of one product, the singular form seems to make more sense.
  4. It is the term used in the heading of the FDA's glossary entry[1] (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]

Note: Upon the creation of this entry, Wikipedia was scoured for use of Biologics License Application and Biological License Application, and these were revised to Biologic License Application; Wiki links to this page were also fixed/added.

See also

References

  1. ↑ 1.0 1.1 FDA: Drugs@FDA Glossary of Terms, "Biologic License Application (BLA)". Accessed 07 July 2010.
  2. ↑ FDA web site search results for "Biologic License Application". Accessed 07 July 2010.
  3. ↑ Google search results for "Biologic License Application". Accessed 07 July 2010.
  4. ↑ Wikipedia web site search results for "Biologic License". Accessed 07 July 2010.
  5. ↑ Federal Register (Vol. 62, No. 16, Friday, January 24, 1997), pp. 3703-3704.
  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.
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