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Blood 137:11541165 Richardson PG, Beksa M, pika I, Mikhael J (2020) Isatuximab for the treatment of relapsed/refractory multiple myeloma

[DOI] [PMC free article] [PubMed] [Google Scholar] 111.Taj A, Jamil N

Can you show, for every sterile product lot youve released in the last 12 months, that final sterility and potency results were received and reviewed before the product reached a patient Again, this firm had an at risk release provision that the FDA found functionally meaningless because there was no documented follow-through

It's a crucial distinction and a common source of frustration

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