Does it support medical device clearance lookups?

Yes, the skill includes capabilities to search for 510(k) clearances, Premarket Approvals (PMA), UDI information, and device classifications.

Can I track drug shortages with this tool?

Yes, the skill provides specific endpoints to monitor current and resolved drug shortages directly from FDA regulatory records.

Is it possible to analyze safety trends over time?

Absolutely. The skill includes design patterns for temporal trend analysis, allowing you to track adverse event frequencies across specific date ranges.

What types of products can I research?

You can research human drugs, medical devices, human food, animal and veterinary products, and specific chemical substances or ingredients.

Do I need an API key to use this skill?

While the skill works without one for low-volume requests (1,000/day), an openFDA API key is recommended for higher rate limits of up to 120,000 requests per day.

FDA Regulatory Data Access

Name: FDA Regulatory Data Access
Author: pur3v4d3r

bypur3v4d3r

•

データサイエンスとML

Queries and analyzes openFDA data for drugs, medical devices, food safety, and adverse events using a standardized Python interface.

概要

The FDA Database Access skill provides a comprehensive interface for querying the openFDA API, enabling researchers and developers to extract critical information about drugs, medical devices, food products, and substances. It facilitates deep-dive analysis of adverse events, recalls, drug labeling, and regulatory submissions, making it an essential tool for pharmacovigilance, medical device surveillance, and food safety research. By providing standardized access to diverse datasets, it simplifies the process of monitoring safety signals and tracking regulatory compliance.

主な機能

Regulatory submission monitoring for 510(k) clearances and PMA approvals
Built-in support for temporal trend analysis and comparative safety profiles
Advanced adverse event tracking and safety signal detection
Multi-domain querying across drugs, devices, foods, and veterinary products
Comprehensive substance lookup using UNII and CAS identifiers
1 GitHub stars

ユースケース

Monitoring product recalls and enforcement actions for food and medical devices
Mapping chemical substances and researching drug interaction trends
Conducting pharmacovigilance and post-market safety surveillance

概要

主な機能

Regulatory submission monitoring for 510(k) clearances and PMA approvals
Built-in support for temporal trend analysis and comparative safety profiles
Advanced adverse event tracking and safety signal detection
Multi-domain querying across drugs, devices, foods, and veterinary products
Comprehensive substance lookup using UNII and CAS identifiers
1 GitHub stars

ユースケース

Monitoring product recalls and enforcement actions for food and medical devices
Mapping chemical substances and researching drug interaction trends
Conducting pharmacovigilance and post-market safety surveillance