Biologic license application

A biologic license application (BLA), short for biological product license application, is defined by the U.S. Food and Drug Administration (FDA) as follows:

Biological [medical] products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm [that] manufactures a biologic [= biological product] 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]

Biological product vs. biologic vs. biologics

Throughout the FDA web site,[2] literature,[3] and Wikipedia,[4] the following variations of the term are used, of which the second and third can be considered typos or grammatical errors:

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,[5] 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[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]

See also

References

  1. 1 2 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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