Legal Aspects of Conducting Clinical Trials Boot Camp/ Symposium Session 5: Legal Considerations of Compassionate Use (2019)


Topics

  1. Legal Considerations of Compassionate Use
  2. 21st Century Cures Act
  3. What is Expanded Access (EA)?
  4. EA Path: Through Manufacturer’s Investigation New Drug Application (IND)
  5. EA Path: EA Investigator Initiated Studies (IIS) - IND
  6. Key Steps for Expanded Access
  7. Manufacturer’s EA Policies
    1. STEP 1 – Contact the Manufacturer
    2. STEP 2 – Plan for your EA Request
    3. STEP 3 – Prepare your EA Request
  8. When the Manufacturer Receives your EA Request
    1. STEP 1 – Engage Level
  9. Adverse Events & Other Concerns
  10. Will the Manufacturer Charge for the Drug?
  11. If the Manufacturer Charges for Drug Costs
  12. FDA Criteria for EA Approval
  13. Case studies: Quiz 1 & 2
  14. Medical Device “Compassionate Use”
  15. Useful References
  16. EAP References

Acknowledgement

Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy | atambe@usc.edu


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.