Completed
The workshop examined the use of the accelerated approval authority for pharmaceuticals and lessons learned. It examined the current regulatory framework for accelerated approvals and explored ways to strengthen the accelerated approval process. It also examined comparable expedited pathways used by other nations' regulatory health authorities and lessons learned from their experiences.
Events
The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals - A Workshop
- January 30 - 31, 2023
- Workshop
- Past
This two-day, virtual workshop featured the following sessions: The U.S. Food and Drug Administration’s Accelerated Approval Program: An Overview Surrogate Markers and Endpoints Confirmatory Trials T...
The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals - A Workshop, Planning Committee Meeting 1
- October 28, 2022
- 3:00 PM - 5:00 PM (ET)
- Meeting
- Past
This will be the first meeting of the planning committee tasked with developing the agenda for The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals - A Workshop.