FDA-regulated Research: Myth vs. Reality – Part 1: Drugs

This session explains common regulatory terms in the context of FDA-regulated drug studies, assesses which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required, navigates the Buck-IRB application sections and documents required for FDA-regulated drug research, and discusses how and when to consult the FDA.

• Presentation Slide Deck
• Watch the FDA-regulated Research: Myth vs. Reality – Part 1: Drugs Video
• FDA Drug Research Resources
• Investigator Tools for Drug Research