FDA BRIEF: Week of May 30, 2016
Release of Final Individual Patient Expanded Access Form
by: Robert Califf, M.D., FDA Commissioner
- FDA has finalized efforts to streamline EXPANDED ACCESS – also called ‘compassionate use’
- Simplified approach for physicians to request expanded access
- Individual Patient Expanded Access Investigational New Drug Application – Form FDA 3926.
- Request expanded access to investigational drugs for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available
Celebrating a Year of the Expedited Access Pathway Program for Medical Devices
Erin Cutts, B.S., Policy Lead, Office of Device Evaluation, CDRH
Owen Faris, Ph.D., Clinical Trials Director, Office of Device Evaluation, CDRH
Jeffrey Shuren, M.D., J.D., Director, CDRH
- CDRH created the voluntary Expedited Access Pathway (EAP) program to facilitate the development of and access to new technology for these patients who desperately need them
- EAP Products ultimately undergo either Premarket Approval (PMA) or de novo review
- Criteria:
- Treat or diagnose life threatening or irreversibly debilitating disease
- Address an unmet need
- Data Development Plan outlining scope of future FDA submission
Final guidances related to expanded access.
- Expanded Access for Individual Patient
- Emergency Expanded Access for an Individual Patient
- Considerations and Regulatory requirements including LOA form sponsor or contact FDA directly
- FDA approval 30 days or sooner
- Expanded access to an investigational drug under a treatment IND or protocol
- Expanded access submissions
Revised regulation for charging for an investigational drug:
- General criteria for authorizing charging
- Criteria for charging in a clinical trial
- Criteria for charging for an expanded access
- Criteria for determining what costs can be recovered when charging