Events Calendar

Emergency Access to Investigational Products

This is a past event.

This session will provide an overview of the process for submitting an Emergency Use Request to the FDA for expanded access to an investigational product. The discussion will provide detailed information on the approach for obtaining access to investigational products and how the O3IS office provides support in this area.    

  • What is expanded access? 
  • Who can request expanded access?
  • What to submit to the FDA?
  • Where to submit?
  • What to submit to the University of Pittsburgh IRB?

Submit advance questions or comments to o3is@pitt.edu.   

Friday, August 16 at 12:00 p.m. to 1:00 p.m.

RCCO Learning Resource Center, 305 3500 Fifth Avenue, Pittsburgh, PA 15213

Emergency Access to Investigational Products

This session will provide an overview of the process for submitting an Emergency Use Request to the FDA for expanded access to an investigational product. The discussion will provide detailed information on the approach for obtaining access to investigational products and how the O3IS office provides support in this area.    

  • What is expanded access? 
  • Who can request expanded access?
  • What to submit to the FDA?
  • Where to submit?
  • What to submit to the University of Pittsburgh IRB?

Submit advance questions or comments to o3is@pitt.edu.   

Friday, August 16 at 12:00 p.m. to 1:00 p.m.

RCCO Learning Resource Center, 305 3500 Fifth Avenue, Pittsburgh, PA 15213

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