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However, as multiple regulatory analysts have noted, the "affordability" rationale alone does not constitute clinical need under the FDA's current framework

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doi: 10.3389/fphar.2024.1372399 Received 18 January 2024 Accepted 25 March 2024 Published 25 April 2024 Volume 15 - 2024 Edited by Xin Wu, Shenyang Pharmaceutical University, China Reviewed by Shyamsundar Pal China, University of California, San Diego, United States Lili Zhang, Chinese Academy of Sciences (CAS), China Updates Copyright 2024 Liu, Xiao, Lin, Zhou, Cheng, Xie and Xu