| name | fda-guideline-search |
| description | Search FDA industry guidelines by therapeutic area or topic.
Trigger when user requests FDA guidance documents, regulatory guidelines,
or asks about FDA requirements for specific disease areas, drug development,
or therapeutic categories (e.g., oncology, cardiology, rare diseases).
Also triggered by queries about FDA ICH guidelines, FDA guidance documents,
or regulatory compliance requirements. |
| version | 1.0.0 |
| category | Pharma |
| tags | [] |
| author | AIPOCH |
| license | MIT |
| status | Draft |
| risk_level | High |
| skill_type | Hybrid (Tool/Script + Network/API) |
| owner | AIPOCH |
| reviewer | |
| last_updated | 2026-02-06 |
FDA Guideline Search
Quickly search and retrieve FDA industry guidelines by therapeutic area.
Features
- Search FDA guidelines by therapeutic area (oncology, cardiology, neurology, etc.)
- Filter by document type (draft, final, ICH guidelines)
- Download and cache guideline documents
- Search within document content
Usage
Python Script
python scripts/main.py --area <therapeutic_area> [options]
Parameters
| Parameter | Type | Default | Required | Description |
|---|
--area | string | - | Yes | Therapeutic area (oncology, cardiology, rare-disease) |
--type | string | all | No | Document type (all, draft, final, ich) |
--year | string | - | No | Filter by year (e.g., 2023, 2020-2024) |
--download | flag | false | No | Download PDF to local cache |
--search | string | - | No | Search term within documents |
--limit | int | 20 | No | Max results (1-100) |
Examples
python scripts/main.py --area oncology
python scripts/main.py --area "rare disease" --type draft
python scripts/main.py --area cardiology --download --limit 10
Technical Details
- Source: FDA CDER/CBER Guidance Documents Database
- API: FDA Open Data / Web scraping with rate limiting
- Cache: Local PDF storage in
references/cache/
- Difficulty: Medium
