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Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Ayalew K, Ning YM, Foringer MJ, Leibenhaut S, Sellers JW, Yu B, Kronstein PD, Higgerson A, Mihaescu C, Rodriguez M, Williams L, Khin NA. Ayalew K, et al. Among authors: higgerson a. Ther Innov Regul Sci. 2023 Jan;57(1):79-85. doi: 10.1007/s43441-022-00441-w. Epub 2022 Aug 16. Ther Innov Regul Sci. 2023. PMID: 35972722 Free PMC article.