Investigational New Drug Application

Before a new drug may be tested on human subjects, the sponsor must submit an Investigational New Drug (IND) application to FDA. The IND must include animal pharmacology and toxicology studies, manufacturing information, clinical protocols, and investigator information.

The IND becomes effective 30 days after submission unless FDA places a clinical hold. Sponsors must report serious adverse events promptly and submit annual progress reports. Institutional Review Board approval is required for all clinical investigations.