Regulatory Services

The Regulatory Services within OCR offers support to Penn faculty who are current IND/IDE Regulatory Sponsors or who are planning to file an IND or IDE Application with the FDA. 

The objectives of the IND/IDE Support Unit are:

  • Provide guidance and templates for the IND/IDE application process;
  • Assist Penn researchers in fulfilling their regulatory responsibilities as an IND/IDE Sponsor;
  • Ensure appropriate sponsor and institutional oversight of IND/IDE trials in which a Penn faculty member is the regulatory sponsor.