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.
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