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Changelog

All notable changes to CTWiseAPI will be documented here.

[1.3.0] - 2026-02-25​

FDA 483 Intelligence - Production Release​

  • 483 Citations Trending - Discover CFR sections with increasing citation frequency via /v1/483/citations/trending
  • Analytics Benchmarks - Compare facility risk scores against peer groups by product type
  • Investigator Profiles - Track investigator inspection patterns and citation rates
  • Facility Watchlist - Monitor specific facilities for new inspection activity (CRUD operations)
  • Risk Scoring v2.0 - Enhanced 5-factor risk methodology including peer benchmarking
  • Data Attribution - Full provenance tracking for all 483 data with source URLs and refresh dates
  • Field Name Standardization - Consistent act_cfr_number field naming across all endpoints

[1.2.0] - 2026-02-15​

FDA 483 Intelligence - Core Features​

  • Regulatory Mapping - CFR-to-ICH E6(R3) cross-references for GCP compliance
  • Facility Citations - Retrieve all citations for a specific facility via /v1/483/facilities/{fei}/citations
  • Enhanced Search Pipeline - 483-specific query expansion with abbreviation recognition and synonym injection
  • Observation Categorization - NLP-based classification into 11 compliance categories
  • 25,000+ Citation Records - Indexed and searchable across 8,100+ facilities

[1.1.0] - 2026-01-30​

FDA 483 Intelligence - Beta Launch​

  • Semantic Search - Natural language search across 25,000+ FDA 483 inspection observations
  • Facility Profiles - Inspection history and classification breakdown by FEI number
  • Risk Scoring - Composite risk scores (0-100) based on OAI ratio, citation frequency, recency, and severity
  • CFR Reference Database - Browse all CFR sections cited in 483 observations with occurrence counts
  • Analytics Summary - Aggregate statistics across all 483 datasets

[1.0.0] - 2025-01-15​

🎉 Initial Release

Added​

  • Core Search API

    • Natural language search across regulatory documents
    • Multi-source support: FDA, ICH, EMA, WHO
    • AI-powered relevance scoring
    • Evidence chain tracing

  • Billing & Subscription

    • AWS Marketplace integration
    • Free tier (1,000 calls/month)
    • Starter tier (10,000 calls/month, $99/month)

  • Developer Experience

    • RESTful API with JSON responses
    • Comprehensive error messages
    • Rate limiting with clear headers
    • API key authentication

  • Documentation

    • Complete API reference
    • Quickstart guide
    • SDK examples (Python, JavaScript, Java, C#)

Sources Included​

SourceDocumentsCoverage
FDA500+Guidance, CFR regulations
ICH100+E-series, Q-series guidelines
EMA200+Scientific guidelines
WHO150+Technical standards

Versioning​

We follow Semantic Versioning:

  • MAJOR: Breaking API changes
  • MINOR: New features (backward compatible)
  • PATCH: Bug fixes (backward compatible)

API Stability​

  • v1 endpoints: Stable, production-ready
  • Breaking changes will be communicated 90 days in advance
  • Deprecated endpoints remain functional for 6 months

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