fda-guideline-search

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

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 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