Regulatory Resources

US FDA - Drugs

• 21 CFR Part 210
• 21 CFR Part 211

US FDA - Medical Device

• 21 CFR Part 820

US FDA - Dietary Supplements

• 21 CFR Part 111

Good Laboratory Practice for Nonclinical Laboratory Studies

• 21 CFR Part 58

Investigational New Drug Application

• 21 CFR Part 312

Applications for FDA Approval to Market a New Drug

• 21 CFR Part 314

• 21 CFR Part 11

• 21 CFR Part 4

Biological Products: General

• 21 CFR Part 600

Human Cells, Tissues, and Cellular and Tissue-Based Products (CGTP)

• 21 CFR Part 1271