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.
Quickly search and retrieve FDA industry guidelines by therapeutic area.
python scripts/main.py --area <therapeutic_area> [options]
| 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) |
# Search oncology guidelines
python scripts/main.py --area oncology
# Search for rare disease draft guidelines
python scripts/main.py --area "rare disease" --type draft
# Search with download
python scripts/main.py --area cardiology --download --limit 10
references/cache/Results are returned as structured JSON:
{
"query": {
"area": "oncology",
"type": "all",
"limit": 20
},
"total_found": 45,
"guidelines": [
{
"title": "Clinical Trial Endpoints for the Approval of Cancer Drugs...",
"document_number": "FDA-2020-D-0623",
"issue_date": "2023-03-15",
"type": "Final",
"therapeutic_area": "Oncology",
"pdf_url": "https://www.fda.gov/.../guidance.pdf",
"local_path": "references/cache/..."
}
]
}
| Risk Indicator | Assessment | Level |
|---|---|---|
| Code Execution | Python scripts with tools | High |
| Network Access | External API calls | High |
| File System Access | Read/write data | Medium |
| Instruction Tampering | Standard prompt guidelines | Low |
| Data Exposure | Data handled securely | Medium |
No additional Python packages required.