Is the data provided in real-time?

The data is sourced directly from openFDA, which updates its datasets regularly. It is ideal for research, trend analysis, and monitoring recent regulatory actions.

Does this skill require an API key to function?

While the skill works without a key (up to 1,000 requests per day), registering for a free openFDA API key is recommended to increase limits to 120,000 requests per day.

Does it support chemical substance research?

Yes, it includes substance lookup capabilities for UNII codes, CAS numbers, and molecular structures to help identify chemical relationships.

Can I analyze adverse events for specific animal breeds?

Yes, the animal and veterinary endpoint allows for species-specific and breed-specific analysis of drug reactions and side effects.

Can I monitor medical device recalls with this tool?

Yes, the skill provides specific endpoints to query device enforcement reports and detailed recall information, including Class I high-risk recalls.

FDA Regulatory Database Access

Name: FDA Regulatory Database Access
Author: Microck

byMicrock

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数据科学与机器学习

Provides programmatic access to openFDA datasets for drug safety research, medical device surveillance, and food recall analysis.

关于

This skill integrates the openFDA API directly into the Claude environment, allowing users to query comprehensive datasets covering human and animal drugs, medical devices, food safety, and substances. It simplifies the retrieval of adverse events, regulatory submissions like 510(k) and PMA approvals, product labeling, and substance identification via UNII or CAS numbers. Designed for researchers and regulatory professionals, it enables complex data analysis tasks such as safety signal detection, temporal trend monitoring, and cross-database lookups through a standardized Python interface.

主要功能

Comprehensive drug lifecycle querying including adverse events and labeling
Medical device surveillance covering 510(k) clearances and PMA data
81 GitHub stars
Substance identification with UNII, CAS, and chemical structure mapping
Food safety monitoring for recalls, allergens, and contamination
Automated pagination and rate limit handling for large datasets

使用场景

Conducting pharmacovigilance and post-market safety signal detection
Researching medical device regulatory history and clearance pathways
Analyzing historical and current drug shortages and supply chain issues

关于

主要功能

Comprehensive drug lifecycle querying including adverse events and labeling
Medical device surveillance covering 510(k) clearances and PMA data
81 GitHub stars
Substance identification with UNII, CAS, and chemical structure mapping
Food safety monitoring for recalls, allergens, and contamination
Automated pagination and rate limit handling for large datasets

使用场景

Conducting pharmacovigilance and post-market safety signal detection
Researching medical device regulatory history and clearance pathways
Analyzing historical and current drug shortages and supply chain issues