fda-database

FDA Database Access

Overview

Access comprehensive FDA regulatory data through openFDA, the FDA's initiative to provide open APIs for public datasets. Query information about drugs, medical devices, foods, animal/veterinary products, and substances using Python with standardized interfaces.

Key capabilities:

• Query adverse events for drugs, devices, foods, and veterinary products
• Access product labeling, approvals, and regulatory submissions
• Monitor recalls and enforcement actions
• Look up National Drug Codes (NDC) and substance identifiers (UNII)
• Analyze device classifications and clearances (510k, PMA)
• Track drug shortages and supply issues
• Research chemical structures and substance relationships

When to Use This Skill

This skill should be used when working with:

• Drug research: Safety profiles, adverse events, labeling, approvals, shortages
• Medical device surveillance: Adverse events, recalls, 510(k) clearances, PMA approvals
• Food safety: Recalls, allergen tracking, adverse events, dietary supplements
• Veterinary medicine: Animal drug adverse events by species and breed
• Chemical/substance data: UNII lookup, CAS number mapping, molecular structures
• Regulatory analysis: Approval pathways, enforcement actions, compliance tracking
• Pharmacovigilance: Post-market surveillance, safety signal detection
• Scientific research: Drug interactions, comparative safety, epidemiological studies

Quick Start

1. Basic Setup

from scripts.fda_query import FDAQuery

# Initialize (API key optional but recommended)
fda = FDAQuery(api_key="YOUR_API_KEY")

# Query drug adverse events
events = fda.query_drug_events("aspirin", limit=100)

# Get drug labeling
label = fda.query_drug_label("Lipitor", brand=True)

# Search device recalls
recalls = fda.query("device", "enforcement",
                   search="classification:Class+I",
                   limit=50)

2. API Key Setup

While the API works without a key, registering provides higher rate limits:

• Without key: 240 requests/min, 1,000/day
• With key: 240 requests/min, 120,000/day