In June 2011, an Investigational New Drug (IND) and Investigational Device Exemption (IDE) service was developed with support from the CCTS. 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.
US Food and Drug Administration (FDA) Links: