FDA BRIEF: Week of May 30, 2016

Voice

 Release of  Final Individual Patient Expanded Access Form

by: Robert Califf, M.D., FDA Commissioner 

califf

  • 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

READ

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 

Erin Cutts  Owen Faris  Jeffrey Shuren

  • 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

READ

 

EA4.JPG

READ

fda guidances

Final guidances related to expanded access.

EA1.JPG

  • 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

READ

EA2.JPG

  • Expanded access to an investigational drug under a treatment IND or protocol
  • Expanded access submissions

 

READ

EA3.JPG

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

READ

 

 

 

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