Investigational New Drug and Investigational Device Exemption Assistance

light bulb.jpgIn 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.

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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 Process
                                            New Drug Application (NDA) 
                                            Abbreviated New Drug Application (ANDA) 
                                            Drug Applications for Over-the-Counter Drugs (OTC) 
                                            Biologic License Application (BLA) 
The UAB CCTS is supported through the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, grant UL1 TR000165.The CTSA program is led by the NIH’s National Center for Advancing Translational Sciences (NCATS). The content of this website is solely the responsibility of UAB and does not necessarily represent the official views of the NIH.