Regulatory Affairs Resources

Regulatory Guidance

• ReGARDD - Drug and device regulatory information and videos

Food and Drug Administration Information and Training

Drug and biologics (CDER/CBER) approval process

• CDER Small Business & Industry Assistance (SBIA)
• Development & Approval Process (CBER)

Tissue Products

• Tissue & Tissue Products

Cellular and Gene Therapy Products

• Cellular & Gene Therapy Products

Device Assistance and classification (CDRH)

• Device Advice: Comprehensive Regulatory Assistance
• Case Study: How is My Medical Device Classified?

Additional Resources

• FDA Approved Drugs
• FDA Medical Device Databases
• FDA Guidance Documents
• European Medicines Agency

Case Studies

• Drug Approval - Bringing a New Drug to the Market
• Device