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The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop

Completed

Topics

Enacted in 2004, the EUA authority allows FDA to sanction on an expedited basis the sale of unapproved medical products for use in public health emergencies. The EUA has become critically important during the COVID-19 pandemic. Nevertheless, the criteria for issuing an EUA are not well-defined in the statute or in FDA regulations. This workshop examined the FDA's historic and recent use of the EUA. We explored possible additional regulatory standards or guidance that could help ensure that EUAs are based on the best scientific evidence and build public confidence the EUA process and products.

About Past Events

Events

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop

  • October 5 - 6, 2021
  • Past

The workshop examined the U.S. Food and Drug Administration’s historic and recent use of the Emergency Use Authorizations (EUAs) for diagnostics, therapeutics, and vaccines. It also provided an overvi...
Meetings

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop - Planning Committee Meeting 4

  • September 17, 2021
  • 10:00 AM - 11:00 AM (EDT)
  • Closed
  • Past

At this final planning meeting, the committee will convene once more to put the finishing touches on preparations for the workshop. This will occur in closed session.

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop - Planning Committee Meeting 3

  • August 17, 2021
  • 12:00 PM - 1:00 PM (EDT)
  • Closed
  • Past

Committee members and staff will continue developing the workshop agenda.

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop - Planning Committee Meeting 2

  • July 13, 2021
  • 11:00 AM - 12:00 PM (EDT)
  • Closed
  • Past

Committee members and staff explored ideas for the draft workshop agenda and developed proposals for speakers to invite.

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: A Workshop - Planning Committee Meeting 1

  • June 22, 2021
  • 4:00 PM - 5:00 PM (EDT)
  • Meeting
  • Past

In this first meeting of the workshop planning committee, members and staff will conduct the bias and conflict of interest discussion, hear presentations from project sponsors and take first steps tow...
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