Events Calendar

14 Jan
FDA Pathway to Expanded Access of Investigational Products
Event Type

Trainings & Workshops

Topic

Research

Target Audience

Staff, Faculty, Residents & Fellows

Website

http://www.orp.pitt.edu

University Unit
Office of Research Protections, Office for Investigator-Sponsored IND and IDE Support
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FDA Pathway to Expanded Access of Investigational Products

Expanded Access is an FDA pathway for a patient with a serious or life-threatening disease or condition to get treatment with an investigational drug, biologic, or device when no comparable or satisfactory therapies are available.  This workshop sheds light on the complexities associated with the expanded access (compassionate use) process.                

  • Basic information and definitions for expanded access to investigational products
  • Categories of Expanded Access
  • Required FDA forms for expanded access submissions
  • FDA expectations for physicians who apply to treat patients using this pathway.

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

Tuesday, January 14 at 1:00 p.m. to 2:00 p.m.

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

FDA Pathway to Expanded Access of Investigational Products

Expanded Access is an FDA pathway for a patient with a serious or life-threatening disease or condition to get treatment with an investigational drug, biologic, or device when no comparable or satisfactory therapies are available.  This workshop sheds light on the complexities associated with the expanded access (compassionate use) process.                

  • Basic information and definitions for expanded access to investigational products
  • Categories of Expanded Access
  • Required FDA forms for expanded access submissions
  • FDA expectations for physicians who apply to treat patients using this pathway.

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

Tuesday, January 14 at 1:00 p.m. to 2:00 p.m.

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

Topic

Research

Target Audience

Staff, Faculty, Residents & Fellows

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