Investigational New Drug and Investigational Device Exemption Assistance

Investigational New Drug and Investigational Device Exemption Assistance

Assistance is available to any investigator on campus who is interested in submitting an IND or IDE application to the FDA.  Services include consultation, actual hands on support during IND preparation, IND management, or simply answering investigator questions.

Though we don't have all the answers, our knowledge and skills are growing.  Our mission is to make an IND/IDE application doable for any investigator on campus.  If you are interested in the IND/IDE service, please contact Penny Jester or Maaike Everts.

View a lecture on IND/IDE by clicking the image to the right.


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US Food and Drug Administration (FDA) Links:  

Investigational New Drug (IND) Application 
Investigational Device Exemption (IDE) Application
Information on the IND/IDE ProcessNew Drug Application (NDA) 
Abbreviated New Drug Application (ANDA) 
Drug Applications for Over-the-Counter Drugs (OTC) 
Biologic License Application (BLA)