Investigational New Drug (IND) & Investigational Device Exemption (IDE) Applications and Maintenance
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 the expertise required to assist investigators submit INDs and IDEs.
- 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. ISIS staff help investigators determine if they need an IND and assist in requesting a determination from the IRB or the FDA. If an IND is required, ISIS staff can help investigators collate the information required for an IND.
- IDE – An investigational device exemption allows investigators to use an investigational device in a clinical study. ISIS staff will help investigators determine if they need to submit an IDE to the FDA and, if so, can assist with collating information required for the IDE application.