Fda Guideline Search

Source: https://github.com/aipoch/medical-research-skills

FDA Guideline Search

Quickly search and retrieve FDA industry guidelines by therapeutic area.

When to Use

• Use this skill when the task needs Search FDA industry guidelines by therapeutic area or topic.
• Use this skill for evidence insight tasks that require explicit assumptions, bounded scope, and a reproducible output format.
• Use this skill when you need a documented fallback path for missing inputs, execution errors, or partial evidence.

Key Features

See ## Features above for related details.

• Scope-focused workflow aligned to: Search FDA industry guidelines by therapeutic area or topic.
• Packaged executable path(s): scripts/main.py.
• Reference material available in references/ for task-specific guidance.
• Structured execution path designed to keep outputs consistent and reviewable.

Dependencies

See ## Prerequisites above for related details.

• Python: 3.10+. Repository baseline for current packaged skills.
• Third-party packages: not explicitly version-pinned in this skill package. Add pinned versions if this skill needs stricter environment control.

Example Usage

See ## Usage above for related details.

cd "20260318/scientific-skills/Evidence Insight/fda-guideline-search"
python -m py_compile scripts/main.py
python scripts/main.py --help

Example run plan:

1. Confirm the user input, output path, and any required config values.
2. Edit the in-file CONFIG block or documented parameters if the script uses fixed settings.
3. Run python scripts/main.py with the validated inputs.
4. Review the generated output and return the final artifact with any assumptions called out.

Implementation Details

See ## Workflow above for related details.

• Execution model: validate the request, choose the packaged workflow, and produce a bounded deliverable.
• Input controls: confirm the source files, scope limits, output format, and acceptance criteria before running any script.
• Primary implementation surface: scripts/main.py.
• Reference guidance: references/ contains supporting rules, prompts, or checklists.
• Parameters to clarify first: input path, output path, scope filters, thresholds, and any domain-specific constraints.
• Output discipline: keep results reproducible, identify assumptions explicitly, and avoid undocumented side effects.

Quick Check

Use this command to verify that the packaged script entry point can be parsed before deeper execution.

python -m py_compile scripts/main.py

Audit-Ready Commands

Use these concrete commands for validation. They are intentionally self-contained and avoid placeholder paths.

python -m py_compile scripts/main.py
python scripts/main.py --help

Workflow

1. Confirm the user objective, required inputs, and non-negotiable constraints before doing detailed work.
2. Validate that the request matches the documented scope and stop early if the task would require unsupported assumptions.
3. Use the packaged script path or the documented reasoning path with only the inputs that are actually available.
4. Return a structured result that separates assumptions, deliverables, risks, and unresolved items.
5. If execution fails or inputs are incomplete, switch to the fallback path and state exactly what blocked full completion.

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

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