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IND/IDE Support

Support for research teams navigating the investigational new drug approval process

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.

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.

FDA Forms

http://www.fda.gov/aboutfda/reportsmanualsforms/forms/default.htm

IND/IDE References

FDA Guidance- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

Guidance for Industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products

Holbein, MEB.  Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators.  J Investig Med 2009; 57:689-695.

Holbein, MEB. Understanding Food and Drug Administration regulatory requirements for an investigational device exemption for sponsor-investigators. J Investig Med 2012;60(7):987-94.

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Related Services Related Pages Related Programs

Protocol Consultation
Data and Safety Monitoring
Research Subject Advocate
IRB/Grant Submission
Consent Document Preparation
MultiCenter IRB Review
Research Ethics
Accelerated Research Agreements Initiative

Good Clinical Practice Training
Acknowledging CTSA grant support in publications

Regulatory Knowledge & Support

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