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Investigational new Drug or Device Exemption Support

eagle-i ID

http://eagle-i.rf.ohio-state.edu/i/0000014b-9d97-9536-3e7e-f9d280000000

Resource Type

  1. Service

Properties

  1. Resource Description
    Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing, and which is required for IRB submission and approval for Ohio State and for Nationwide Children’s Hospital . For clinical trials involving marketed drug(s) for alternative use an IND Exemption may be an acceptable alternative. The CCTS, in collaboration with the OSU Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.
  2. Contact
    0000014b-9d86-1b80-3e7e-f9d280000000
  3. Service Provided by
    Regulatory Knowledge and Support
  4. Website(s)
    https://ccts.osu.edu/research-support-services/regulatory-and-ethics/IND-support
 
RDFRDF
 
Provenance Metadata About This Resource Record