fda-guideline-search
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.
Install via CLI (Recommended)
clawhub install openclaw/skills/skills/aipoch-ai/fda-guideline-searchFDA 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
# 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
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
Output Format
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/..."
}
]
}
References
- FDA Search Strategy
- Therapeutic Area Mappings
- FDA API Documentation
Limitations
- Rate limited to 10 requests/minute to respect FDA servers
- Some historical documents may not have digital PDFs
- ICH guidelines require separate search scope
Risk Assessment
| 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 |
Security Checklist
Metadata
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Find the right skillPaste this into your clawhub.json to enable this plugin.
{
"plugins": {
"official-aipoch-ai-fda-guideline-search": {
"enabled": true,
"auto_update": true
}
}
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