# OnCo record bla-nda (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/bla-nda/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "bla-nda" ;
  schema:name "BLA / NDA / MAA (marketing applications) and PDUFA dates"@en ;
  schema:alternateName "BLA"@en, "NDA"@en, "MAA"@en, "biologics license application"@en, "new drug application"@en, "marketing authorisation application"@en, "marketing application"@en, "regulatory submission"@en, "filing accepted"@en, "submission accepted"@en, "regulatory review"@en, "PDUFA"@en, "PDUFA date"@en, "action date"@en, "target action date"@en, "goal date"@en, "rolling submission"@en, "standard review"@en, "10-month review"@en, "6-month review"@en, "new drug applications"@en, "regulatory submissions"@en ;
  schema:description "The formal application to sell a drug: a New Drug Application for small molecules, a Biologics License Application for antibodies and cell therapies (US), or a Marketing Authorisation Application (EU). The PDUFA date is the deadline by which the FDA has promised a decision."@en ;
  schema:url <https://onco.cc/terms/bla-nda/> ;
  schema:dateModified "2026-09-09"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act> ;
  schema:citation <https://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act> ;
  onco:related <https://onco.cc/terms/label-indication/>, <https://onco.cc/terms/complete-response-letter/>, <https://onco.cc/terms/breakthrough-designation/>, <https://onco.cc/terms/regulatory-agencies/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:technologies <https://onco.cc/terms/real-time-oncology-review/>, <https://onco.cc/terms/project-orbis/> .