Resources for Foreign Pharmaceutical Regulatory Authorities

FDA Overview

• Overview of FDA Review Process for Investigational New Drugs
• Overview of FDA’s Regulatory Review and Research Activities

FDA Review Processes

• Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
• Biosimilar Biological Products
• Abbreviated New Drugs

Technical Standards

• Electronic Common Technical Document
• Electronic Transmission of Individual Case Safety Reports Implementation Guide (E2B(R3))

Searchable database for FDA Guidance documents:

• Search for FDA Guidance Documents

External Resources

• Training for ICH Guidelines

For more information contact: CDERINTLEXEC@fda.hhs.gov