fda-guideline-search

# 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 ```bash 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 ```bash # 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: ```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](./references/search-strategy.md) - [Therapeutic Area Mappings](./references/area-mappings.json) - [FDA API Documentation](./references/fda-api-notes.md) ## Limitations - Rate limited to 10 requests/minute to respect FDA servers - Some historical documents may not have digital PDFs - ICH guidelines require separate search scope ## Risk Assessment | Risk Indicator | Assessment | Level |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 1. **Basic Functionality**: Standard input → Expected output 2. **Edge Case**: Invalid input → Graceful error handling 3. **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