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FDA has identified potential significant safety risks when reviewing nominations for bulk drug substances proposed to be included on the sections 503A or 503B bulks lists

[PubMed: 37364590] Lau DCW, Erichsen L, Francisco AM, et al

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Cryo-EM data processing RELION-3.1.2 were used for all data processing to yield the polished particle stack that was subjected into cryoSPARC v4.4.1 for 3D reconstitution 28,29