Regulatory Group

In support of investigational new drug (IND) applications, the Regulatory Group:

• Prepares and submits new IND applications and serial submissions
• Prepares IND annual progress reports; assists investigators with writing Investigator Brochures
• Reviews protocols to ensure that they comply with FDA regulations, Good Clinical Practice (GCP) guidelines, and NIH policy
• Acts as a liaison between the Principal Investigator and the Food and Drug Administration (FDA)