What types of products can I research with this skill?

You can research human drugs, medical devices, food products, dietary supplements, and animal/veterinary medications.

Do I need an API key for the FDA Database skill?

While the skill works without one, registering for an openFDA API key increases your daily limit from 1,000 to 120,000 requests.

Can I track specific medical device approvals?

Yes, the skill allows you to query 510(k) clearances and Premarket Approval (PMA) data for Class III devices.

Does this skill support trend analysis over time?

Yes, it includes query patterns for temporal trend analysis to monitor safety signals over specific date ranges.

Is this skill suitable for professional pharmacovigilance?

It provides a powerful tool for post-market surveillance and safety signal detection, though users should always consult official FDA sources for final verification.

FDA Regulatory Data Access

Name: FDA Regulatory Data Access
Author: Microck

byMicrock

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データサイエンスとML

Accesses and analyzes comprehensive FDA regulatory data for drugs, medical devices, and food safety through the openFDA API.

概要

This skill provides a specialized interface for Claude to query the openFDA database, enabling detailed research into pharmaceutical safety profiles, medical device clearances, and food recall histories. It simplifies complex API interactions for tasks like drug adverse event monitoring, National Drug Code (NDC) lookups, and tracking 510(k) or PMA submissions. Whether for pharmacovigilance, scientific research, or regulatory compliance, this skill allows users to extract actionable insights from public health datasets using standardized Python implementation patterns.

主な機能

Medical device surveillance and 510(k)/PMA clearance tracking
Comprehensive drug adverse event and labeling analysis
Food safety monitoring including allergen and recall alerts
Chemical substance identification via UNII and CAS mapping
Temporal trend analysis for safety signal detection
81 GitHub stars

ユースケース

Medical device market research and regulatory history tracking
Pharmacovigilance and drug safety profile generation
Food industry compliance and recall monitoring

概要

主な機能

Medical device surveillance and 510(k)/PMA clearance tracking
Comprehensive drug adverse event and labeling analysis
Food safety monitoring including allergen and recall alerts
Chemical substance identification via UNII and CAS mapping
Temporal trend analysis for safety signal detection
81 GitHub stars

ユースケース

Medical device market research and regulatory history tracking
Pharmacovigilance and drug safety profile generation
Food industry compliance and recall monitoring