Investigational New Drug

The IND is an application that sponsors or investigators must submit to the FDA to receive an exemption to transport or distribute drugs across state lines.

The IND must state the purpose to test the agent in human subjects and supply pre-clinical data and justification to warrant clinical studies.  The application must be submitted prior to the start of any human subject research studies.  The research study cannot begin participant recruitment until 30 days after FDA receipt or after all FDA requests have been fulfilled.  INDs require annual updates to reflect protocol changes, new information, or serious adverse events.