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Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.
Krastein J, Pica-Branco D, Bacho MA, Mulugeta Y, Maynard JW, Alexander JJ, Yao L, Hausman ED. Krastein J, et al. Among authors: bacho ma. Ther Innov Regul Sci. 2023 Sep;57(5):1099-1103. doi: 10.1007/s43441-023-00551-z. Epub 2023 Jun 30. Ther Innov Regul Sci. 2023. PMID: 37389793