<aside> 📊 202 FDA Complete Response Letters analyzed for regulatory intelligence — deficiency patterns, therapeutic area trends, and sentiment scoring.

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GitHub: prahlaadr/fda-crl-analyzer

What It Does

Parses FDA Complete Response Letters (CRLs) — rejection letters sent to drug sponsors — and extracts structured data: deficiency categories, therapeutic areas, severity, and sentiment. Enables trend analysis across 5 years of FDA decisions.

Key Findings

• 8 deficiency categories — Clinical, CMC, Safety, Labeling, Statistical, Nonclinical, Regulatory, Other
• 7 therapeutic areas — Oncology, Neurology, Infectious Disease, Cardiology, Metabolic, Rare Disease, Other
• Clinical deficiencies are the #1 reason for CRLs across all therapeutic areas

Stack

• DuckDB — SQL analytics over Parquet files
• Polars — Data transformation and aggregation
• Parquet — Columnar storage for 202 analyzed letters