Investigational New Drug (IND)

An Investigational New Drug (IND) is a designation given by the U.S. Food and Drug Administration (FDA) that allows a pharmaceutical company or researcher to start testing a new drug in humans. This process begins after preclinical studies show the drug is potentially safe and effective. The IND application includes data about the drug, its manufacturing, and the planned clinical trial. Gaining IND status is crucial for ensuring that the drug is thoroughly evaluated for safety and efficacy before it can be considered for approval and available to the public.