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...
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 |
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Format: | Article |
Language: | English |
Published: |
Public Library of Science (PLoS)
2022-01-01
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Series: | PLoS ONE |
Online Access: | https://doi.org/10.1371/journal.pone.0265712 |
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