IND, IDE or EUA-related protocols policy
YCCI provides a comprehensive, centralized resource for FDA submission of Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), with staff members and consultants with Industry experience who provide “soup to nuts” IND/IDE support.
New Policy Regarding IND, IDE or EUA-related protocols
Effective May 1, 2021, a Yale Investigator who intends to conduct an investigation/project that requires an IND, IDE or EUA must submit for review to the YCCI IND/IDE Management Office. The Office must receive IND/IDE/EUA applications either before or contemporaneously with their submission to the FDA and the Yale HRPP for IRB review, as applicable. Submissions of proposals to the HRPP requiring an IND/IDE that have not been previously reviewed or approved by the Office will be routed to the Office by the HRPP prior to IRB review and approval.
To whom does the policy apply?
Investigators at the Yale School of Medicine who hold, or are considering holding with the US Food and Drug Administration (FDA):
- Investigational New Drug Applications (INDs) including Compassionate use/Expanded access
- Investigational Device Exemptions (IDEs) including Compassionate use/Expanded access
- Emergency Use Authorizations (EUA)
For assistance, contact Amy Hummel at the YCCI IND/IDE Management Office for guidance by emailing email@example.com.