Resources

Industry Resources
& Reference Library

Curated links to essential regulatory guidance, industry standards, and reference materials for life sciences professionals.

ICH Guidelines

International Council for Harmonisation technical requirements

ICH E6(R3) Good Clinical Practice

Updated GCP guidelines for clinical trials including decentralized trials

ICH Q9 Quality Risk Management

Principles and examples of quality risk management tools

ICH Q10 Pharmaceutical Quality System

Model for an effective pharmaceutical quality system

FDA Medical Devices

Device regulation, submissions, and guidance documents

CDRH Learn: Device Regulation Overview

FDA's educational resource on medical device classification and pathways

510(k) Premarket Notification

Guidance on 510(k) submissions and substantial equivalence

Device Advice: Comprehensive Regulatory Assistance

Complete guide to FDA medical device requirements

Companion Diagnostics

In vitro diagnostics paired with therapeutic products

FDA Companion Diagnostics Guidance

Principles for codevelopment of therapeutic and diagnostic products

List of Cleared or Approved Companion Diagnostics

FDA database of approved companion diagnostic devices

Biomarker Qualification Program

FDA program for qualifying biomarkers for drug development

AI & Machine Learning

Regulatory frameworks for AI/ML in healthcare and life sciences

FDA AI/ML-Based Software as Medical Device

Action plan and guidance for AI/ML-enabled medical devices

EU AI Act Overview

European Commission's regulatory framework for artificial intelligence

WHO Guidance on AI for Health

Ethics and governance of artificial intelligence for health

FDA Digital Health Center of Excellence

Resources on digital health technologies including AI/ML

Additional Resources

Industry standards and regulatory databases

FDA Drugs Database

Search approved drug products and labeling

ClinicalTrials.gov

Database of clinical studies conducted around the world

EMA Guidelines

European Medicines Agency scientific guidelines

These resources are provided for informational purposes only. Links are to official external sources. Always verify current guidance directly with the relevant regulatory authority.

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Industry Resources& Reference Library