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- Some historical documents may not have digital PDFs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