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Our Work Workshop The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals - A Workshop

The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals - A Workshop

Completed

Regional focus

Global

Topics

Legislation and Policy

Health and Medicine

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.

About Past Events

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...

Meetings

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 (EDT)

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.

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