- name
- fda-guideline-search
- description
- Search FDA industry guidelines by therapeutic area or topic.
- 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
# 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 10Technical 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
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- Some historical documents may not have digital PDFs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
- [ ] No hardcoded credentials or API keys
- [ ] No unauthorized file system access (../)
- [ ] Output does not expose sensitive information
- [ ] Prompt injection protections in place
- [ ] API requests use HTTPS only
- [ ] Input validated against allowed patterns
- [ ] API timeout and retry mechanisms implemented
- [ ] Output directory restricted to workspace
- [ ] Script execution in sandboxed environment
- [ ] Error messages sanitized (no internal paths exposed)
- [ ] Dependencies audited
- [ ] No exposure of internal service architecture
Prerequisites
No additional Python packages required.
Evaluation Criteria
Success Metrics
- [ ] Successfully executes main functionality
- [ ] Output meets quality standards
- [ ] Handles edge cases gracefully
- [ ] Performance is acceptable
Test Cases
- Basic Functionality: Standard input → Expected output
- Edge Case: Invalid input → Graceful error handling
- Performance: Large dataset → Acceptable processing time
Lifecycle Status
- Current Stage: Draft
- Next Review Date: 2026-03-06
- Known Issues: None
- Planned Improvements:
- Performance optimization - Additional feature support