Drugs/Biologics
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
- FDA website for investigators
- Guidance for industry - E6(R2) good clinical practice: Integrated addendum to ICH E6(R1)
- FDA IND forms:
- Form 1571 (instructions)
- Form 1572 (instructions)
- Form 3674
- Form 3454
- Form 3455
IND general information
- IND flowchart
- Determination of IND exemption for marketed drugs
- Step-by-step guide to submitting an IND
- Sponsor and investigator responsibilities
- Timetable for submission of required reports
- Required amendments and reports
IND templates
- Concurrence of exemption
- Letter of authorization to refer to your IND
- IND amendment: change in protocol
- IND amendment: new protocol
- IND amendment: new investigator
- IND annual report
- IND final report
- IND withdrawal request
- IND inactivation request
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
kanigherl@vcu.edu
Brendan Baggot
Clinical research monitor
FDA program administrator
baggotb@vcu.edu
Regulatory affairs
indide@vcu.edu