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.
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Workshop_in_brief
·2023
Accelerated approval provides a process for hastening access to innovative interventions for patients with serious or life-threatening diseases for which no other options are available. However, accelerated approval has been, at times, controversial due to uncertainties related to whether pharmaceut...
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Description
A planning committee of the National Academies of Sciences, Engineering, and Medicine will convene a virtual workshop to examine the U.S. Food and Drug Administration’s use of the accelerated approval program for new pharmaceuticals. The workshop will: 1) review use of accelerated approval, including instances when its use has been controversial; 2) provide an overview of the regulatory process for accelerated approval of drugs: 3) examine similar processes used by other nations' health regulatory entities; and 4) consider approaches for strengthening the accelerated approval process. A proceedings in brief will be issued following the workshop.
Collaborators
Committee
Co-Chair
Co-Chair
Member
Member
Member
Member
Steven R. Kendall
Staff Officer
Sponsors
Arnold Ventures
Commonwealth Fund
Kaiser Permanente
Staff
Steven Kendall
Lead
Renee Daly
Anne-Marie Mazza
