Investigational New Drug (IND) & Investigational Device Exemption (IDE) Consultation
When studies involve drugs or devices not approved by the Food & Drug Administration (FDA), or drugs or devices used for purposes not approved by the FDA which pose an increased risk, investigators are required to get clearance from the FDA prior to enrolling subjects in their study. OCTRI compliance experts have experience in determining whether a drug or device requires and IND or IDE and can consult on the application process.
- IND – An investigational new drug application to the FDA is required for drugs not yet FDA approved and some uses of FDA-approved drugs for a non-FDA-approved purpose or population. OCTRI can help investigators determine if they need an IND and advise you in requesting a determination from the IRB or the FDA. If an IND is required, OCTRI can advise investigators on what information is required for an IND.
- IDE – An investigational device exemption allows investigators to use an investigational device in a clinical study. OCTRI staff will help investigators determine if they need to submit an IDE to the FDA and, if so, can advise on what information is required for the IDE application.