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CRISPR-Cas9-edited SNCA knockout human induced pluripotent stem cell-derived dopaminergic neurons and their vulnerability to neurotoxicity
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While 503B outsourcing facilities are subject to federal Current Good Manufacturing Practice (CGMP) regulations and must register with the FDA, traditional 503A compounders are exempt from CGMP regulations and are instead overseen primarily by state boards of pharmacy, potentially resulting in a patchwork of manufacturing regulation and oversight across states (Lisi, 2021

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