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Search FDA CBER Approval Documents

Search and read FDA CBER Approval Documents records through the Assyro API: the approval letters, SBRAs, review memos and labeling CBER posts for the…

GEThttps://api.assyro.com/v1/sources/fda-cber-approvals/search

Preview: api.assyro.com is not serving production data yet. This page follows the API's published description and may change before launch.

Search and read FDA CBER Approval Documents records from your own code: the approval letters, SBRAs, review memos and labeling CBER posts for the biologics it licenses (vaccines, blood products, cell and gene therapies), cited by product and document. Published by U.S. Food and Drug Administration (www.fda.gov/vaccines-blood-biologics/cber-regulated-products-supporting-documents); answered from Assyro's copy, refreshed daily 21:30 UTC.

Licence: public domain (see the terms). Each record links to its page at the source.

Example: "What did CBER's summary basis for regulatory action say about ZOLGENSMA?"

Search

GET https://api.assyro.com/v1/sources/fda-cber-approvals/search with any of these query parameters. Repeat a parameter for a list (?phase=PHASE2&phase=PHASE3). An unknown parameter is refused by name.

Search parameters

  • querystring

    Words in the document's title or text, e.g. "potency assay" or "accelerated approval confirmatory".

  • productstring

    Trade name or proper name, e.g. "ZOLGENSMA" or "onasemnogene abeparvovec".

  • manufacturerstring

    The license holder, e.g. "Novartis Gene Therapies".

  • documentKindstring

    Only one kind of document. One of: approval letter, labeling, summary basis for regulatory action, review, approval history, summary of safety and effectiveness, demographic subgroup information, other.

  • dateFromstring

    Documents dated on or after this date (the date in the document's title, e.g. an approval letter's), YYYY-MM-DD.

  • dateTostring

    Documents dated on or before this date, YYYY-MM-DD.

  • limitinteger

    Documents to return, default 8.

  • offsetinteger

    Skip this many results (for paging), default 0.

Each result is a record; read one in full with Get a record.

What a record holds

  • id, title, url: the source's identifier, its title and its page at the source, to verify it.
  • authority, publishedDate, version: who published it, when, and the edition read.
  • snippet and fields: the matching text and the source's own fields.
  • asOf: the day Assyro's copy of the source was read.