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HalseyYang
HalseyYangCOMMUNITY
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fda-guideline-search

Search FDA industry guidance documents by therapeutic area via a Python CLI.

1|Updated Jul 13, 2026
Search Tags:#search#fda#regulatory affairs#pharma#guidance documents#therapeutic area#ich guidelines
One-click install
npx skills add https://github.com/HalseyYang/Skills-HY --skill fda-guideline-search-halseyyang
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: fda-guideline-search
Source: https://github.com/HalseyYang/Skills-HY/tree/main/fda-guideline-search
Command: npx skills add https://github.com/HalseyYang/Skills-HY --skill fda-guideline-search-halseyyang

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve? Regulatory affairs and clinical development teams need to locate relevant FDA and ICH guidance documents for specific therapeutic areas, but the FDA offers no dedicated public REST API for guidance documents, making manual searching slow and repetitive. ## Core Features & Use Cases - Therapeutic Area Search: Search FDA guidance across 16 mapped therapeutic areas (oncology, cardiology, rare disease, etc.) with keyword and alias normalization. - Filtering & Download: Filter results by document type (draft, final, ICH) and year range, with optional PDF download to a local cache directory. - Structured JSON Output: Returns document numbers, issue dates, types, and PDF URLs in structured JSON for downstream processing. - Use Case: A regulatory affairs specialist preparing an oncology drug submission runs a search for oncology final guidance documents from 2020-2024 to compile the applicable FDA requirements. ## Quick Start Ask the AI to search FDA guidance documents for the oncology therapeutic area and list the most recent final guidelines.

Frequently Asked Questions about fda-guideline-search

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I search FDA guidance documents by therapeutic area?▼

Run the Python CLI with the --area flag, for example: python scripts/main.py --area oncology. You can add --type, --year, and --limit flags to filter by document type, date range, and result count.

What therapeutic areas does the FDA guidance search support?▼

It supports 16 mapped areas including oncology, cardiology, neurology, rare disease, infectious diseases, immunology, and pediatrics. Run the script with --list-areas to see the full list, and common aliases like cancer or orphan are normalized automatically.

Does the FDA provide an official API for guidance documents?▼

No, the FDA does not currently offer a dedicated public REST API for guidance documents. The openFDA API covers adverse events, labels, and recalls but not full guidance text, so this tool relies on web scraping with rate limiting.

Are the search results from this tool authoritative FDA data?▼

No, the results are non-authoritative demonstration data with a sample structure. Always verify any cited guidance directly against official FDA or ICH sources before using it in regulatory work.

What are the limitations of searching FDA guidance via web scraping?▼

Requests are rate-limited to 10 per minute with 6-second delays, some historical documents lack digital PDFs, and ICH guidelines require separate database access. Document numbers and URLs may also change over time.

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