Regulatory Science Symposium: Legal Aspects of Conducting Clinical Trials Session 5: Legal Considerations of Compassionate Use (2019)


  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


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |

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