A framework for assessing the impact of accelerated approval.

The FDA's Accelerated Approval program (AA) is a regulatory program to expedite availability of products to treat serious or life-threatening illnesses that lack effective treatment alternatives. Ideally, all of the many stakeholders such as patients, physicians, regulators, and health technolo...

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Bibliographic Details
Main Authors: A Lawrence Gould, Robert K Campbell, John W Loewy, Robert A Beckman, Jyotirmoy Dey, Anja Schiel, Carl-Fredrik Burman, Joey Zhou, Zoran Antonijevic, Eva R Miller, Rui Tang
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2022-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0265712