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

1. Legal Considerations of Compassionate Use
2. 21^st 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 | atambe@usc.edu