Investigational New Drug Application (IND)

IND

Regulatory

An FDA submission required before a new drug can be administered to humans in clinical trials. Contains preclinical data, manufacturing information, and the clinical protocol.

Examples

30-day safety review
IND-enabling studies
Treatment IND for serious conditions

Did You Know?

An FDA submission required before a new drug can be administered to humans in clinical trials. Contains preclinical data, manufacturing information, and the clinical protocol.