Skill: aipoch-ai/fda-guideline-search (version 0.1.0)

--- 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 ```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


Security scan verdicts — ClawScan: suspicious | static analysis: clean | VirusTotal: clean | SkillSpector: suspicious (CRITICAL)