Drug Approvals and Adverse-Event Summary¶
This reference covers the new Drugs@FDA approvals section and FAERS summary statistics.
Drug approvals (Drugs@FDA)¶
Use the approvals section on drug entities:
The section includes:
- application number (NDA/BLA),
- sponsor,
- key product rows (brand/dosage form/route/status),
- submission timeline rows (type/number/status/date).
FAERS summary statistics¶
FAERS search responses include summary metadata above the report table:
Summary fields:
- total reports from OpenFDA metadata,
- returned report count,
- top reactions with count and percentage.
The same summary appears in: