Events Calendar

21 Feb
Expanded Access to Investigational Products
Event Type

Trainings & Workshops

Topic

Research

Target Audience

Staff, Faculty, Graduate Students

Website

http://www.rcco.pitt.edu

Group
Pittwire, University Times, @Pitt
Subscribe
Google Calendar iCal Outlook

Expanded Access to Investigational Products

This presentation provides an overview of FDA’s Expanded Access Program which, permits pre-approval access to drugs in development. The discussion will address the following:

  • Basic information and definitions for expanded access
  • Review of expanded access categories
  • Required FDA forms for expanded access submissionAn overview of FDA expectations for physicians who apply to treat patients using this pathway.

No registration required. Submit advance questions or comments to o3is@pitt.edu.

Thursday, February 21 at 1:00 p.m. to 2:00 p.m.

Magee-Womens Research Institute 204 Craft Avenue Pittsburgh, 15213