Online Course: Investigational New Drug (IND) and Investigational Device Exemption (IDE) Orientation Module
This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.
IND Resources
FDA Guidance - Determining Whether Human Research Studies Can Be Conducted Without an IND
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects require an Investigational New Drug application (IND).
IDE Resources
FDA Guidance - Significant Risk and Nonsignificant Risk Medical Device Studies
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies require an Investigational Device Exemption (IDE).