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Investigational drugs or biological products must be studied under an Investigation New Drug Application (IND) if the indication and the manner they are being used is not approved for marketing by the FDA. Drug INDs are managed through the Center for Drug Evaluation and Research within the FDA. Biologic INDs are managed through the Center for Biologics Evaluation and Research within the FDA. If you are unsure whether your study would require an IND or if it meets the criteria for IND exemption, please contact the FDA program at VCU at indide@vcu.edu.  

FDA regulations

FDA guidance and forms

IND general information

IND templates

IND education

  • On-demand investigational new drug application sponsor and investigator training modules are available through Talent@VCU or Canvas.
  • Access modules in Talent@VCU
    • If you have not logged into Talent in the past 24 hours, you will need to log into talent then search for the training module “Investigational New Drug Application (IND) Sponsor and Investigator Training Modules”
  • Access modules in Canvas

Contact us

Lauren Wallace, MS, RAC-Drugs
Director of clinical research regulatory affairs

Brendan Baggot
Clinical research monitor
FDA program administrator

Regulatory affairs