ASassyro
FDA CBER Approval Documents

Search FDA CBER Approval Documents

Search the documents CBER posts for the biologics it licenses (vaccines, blood and blood products, cellular and gene therapies, tissue products, allergenics): approval letters, summaries basis for regulatory action (SBRA), clinical, statistical and other review memos, package inserts and approval histories, with their full text. CDER's biologics are in Drugs@FDA, not here. Find by product (trade or proper name), manufacturer, words in the text, document kind or date. Each result gives the product, manufacturer, document kind and date. Call read_cber_approval_document for the text.

get/v1/sources/fda-cber-approvals/search

Request

  • Base URL
    https://api.assyro.com
  • Auth
    none declared

Query 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".

documentKind'approval letter' | 'labeling' | 'summary basis for regulatory action' | 'review' | 'approval history' | 'summary of safety and effectiveness' | 'demographic subgroup information' | 'other'

Only one kind of document.

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.

Response

Matching records.

versionunknown required
totalinteger nullable required

Total matches the source reports, when it says.

notestring
summarystring[]

Changes

No recorded changes to this operation across all 1 revision of this API.