Approval pathways, review history, and regulatory status
Regulatory teams use this context to reconstruct product history without parsing authority-specific files.
Complete drug approval history, submission types, review priority flags, CRL tracking, accelerated pathway designations (Breakthrough, Fast Track, Accelerated Approval). Every NDA and BLA submission action from first filing to current status.
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Overview
Regulatory teams use this context to reconstruct product history without parsing authority-specific files.
Complete drug approval history, submission types, review priority flags, CRL tracking, accelerated pathway designations (Breakthrough, Fast Track, Accelerated Approval). Every NDA and BLA submission action from first filing to current status.
Analyze approval, label, safety, REMS, biologic, small molecule, and NDC records without source-specific parsing work.
Join NDA, BLA, NDC, RxCUI, UNII, SPL set ID, patent, and exclusivity identifiers through the drug identity spine.
Model regulatory timelines, indication expansion, label change velocity, and eligibility clocks with curated fields.
Trace every normalized attribute back to the official FDA or NLM source authority.
Source authority
U.S. Food and Drug Administration — Drugs@FDA
Freshness
Last refreshed 2026-09-01
Monthly
Coverage
400K+
2 delivery tables