Skip to main content
  • Dataset id: fda_biologic
  • Jurisdiction: US · FDA
  • Date field: date. The search’s top-level date_from and date_to filter on it.
  • Access: any API key.

​
Filters

Send these under filters.fda_biologic in a search request. A filter not listed here, or a value of the wrong type, is a 400. The top-level date_from and date_to set date_from and date_to below, so give a date in one place only.
​
string
Keyword match on product name (BM25 tokenized). Example: ‘Keytruda’.
​
string
Keyword match on applicant company (BM25 tokenized). Example: ‘Pfizer’.
​
string
Exact application number. Example: ‘BLA 125514’.
​
string (date)
Inclusive lower bound on date (YYYY-MM-DD).
​
string (date)
Inclusive upper bound on date (YYYY-MM-DD).
​
string
Filter by application type derived from app_number prefix. BLA = Biologics License Application, NDA = New Drug Application, PMA = Premarket Approval, 510(k) = Substantially Equivalent device, De Novo = Novel low-risk device.Values: BLA, NDA, PMA, 510(k), De Novo.
​
string
Exact supplement (sBLA) suffix parsed from the STN, e.g. ‘656’ for STN 125742/656.
​
string
Filter to ‘original’ (initial BLA, no supplement number), ‘supplement’ (sBLAs — new indications, age groups, annual formula updates, labeling/CMC changes), or ‘any’ (default). Use ‘supplement’ for questions about what new indications or sBLAs a product or CBER received.Values: any, original, supplement.

​
Fields

Each result from this dataset has these in fields: app_number, application_type, company, date, fda_url, name, product_url, rhizome_url, supplement_number