Definition
BLA appears in historical legal sources as an abbreviated or fragmentary reference, most likely to the coif — the white silk cap worn by serjeants at law as a badge of their order. In this historical context, BLA functions not as a standalone legal term but as a remnant of surrounding text describing the ceremonial headwear with which serjeants at law were invested at their creation. The coif was distinctive enough that serjeants were obligated to keep it upon their heads at all times, even in the presence of the sovereign, a rule that set them apart from all other legal officers and became one of the most recognizable marks of their degree.
In modern administrative and regulatory usage, BLA is an initialism for Biological License Application — the formal submission made to the U.S. Food and Drug Administration (FDA) seeking approval to manufacture and market a biological product (such as a vaccine, blood product, or therapeutic protein) in interstate commerce. This usage is entirely distinct from the historical legal context and arises from federal regulatory law rather than common law tradition.
Common Language
Modern common usage (Wiktionary): Initialism of biological licence application.
Historical common usage: Not separately defined in Webster's 1913 as an initialism or legal abbreviation.
Editorial note: The regulatory meaning of BLA (Biological License Application) is a product of twentieth-century administrative law and has no connection to the historical legal usage found in Burrill. Researchers encountering BLA in different corpus contexts are effectively encountering two entirely unrelated terms sharing a three-letter form.
Common Confusion
BLA should not be confused with NDA (New Drug Application), which is the parallel FDA pathway for conventional (non-biological) drug products. Both are pre-market approval mechanisms, but they govern different categories of products under different statutory frameworks. Additionally, researchers working in historical legal sources should be careful not to import the modern regulatory meaning into passages where BLA or similar abbreviations appear in the context of serjeants at law, legal ceremony, or the Inns of Court.
Why It Matters in Research
This entry presents a significant disambiguation challenge. The fragment appearing in Burrill's Law Dictionary is not a definition of BLA as a term of art but rather a portion of a longer passage about the coif worn by serjeants at law — a description drawn from Fortescue's De Laudibus Legum Angliae. Researchers using the Law Mind corpus should treat the Burrill passage as contextual background for understanding the serjeant's coif rather than as evidence that BLA was a recognized legal term.
For researchers working in FDA regulatory law, BLA is a critical term of art. Biological License Applications are governed by the Public Health Service Act and implementing FDA regulations, and the distinction between BLA and NDA pathways has practical consequences for patent exclusivity, interchangeability determinations, and biosimilar approval. Historical legal dictionaries provide no guidance here whatsoever.
The two usages are corpus-separated: historical legal dictionaries (Burrill, Black's early editions, Bouvier) will never address the regulatory meaning, and modern regulatory sources will never address the serjeant's coif. Researchers should confirm which corpus layer they are working in before treating any source's silence as meaningful.
Historical Dictionary Support
Burrill's Law Dictionary does not define BLA as an independent term. The passage in which BLA appears is part of a longer description of the coif — the white silk headcovering that was the defining insignia of serjeants at law in the English common law tradition. Burrill draws on Sir John Fortescue's De Laudibus Legum Angliae for this account, a fifteenth-century work that remains a primary source on the organization of the English legal profession. Fortescue's account confirms that the coif was never removed even before royalty, a rule that distinguished serjeants from virtually every other subject in the realm.
No other historical dictionary in the standard legal reference shelf (Black's, Bouvier, Tomlin, Jacob) treats BLA as a defined term. The Burrill fragment should be read as marginalia or a cross-reference anchor rather than a term entry in its own right.
Jurisdictional Note
The regulatory meaning of BLA is specific to United States federal law under the jurisdiction of the FDA. Other countries use different terminology and application frameworks for biological products. The historical ceremonial meaning relates exclusively to the English common law tradition and has no jurisdictional analog in American law.