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J Clin Med 9:1195 Saltarella I, Desantis V, Melaccio A, Solimando AG, Lamanuzzi A, Ria R et al (2020) Mechanisms of resistance to anti-CD38 daratumumab in multiple myeloma

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The FDA has not reviewed safety data, efficacy data, or quality control standards for these mixed formulations

Application of the 2 Times Rule Section 1833(t)(9)(A) of the Act requires the Secretary to review, not less often than annually, and revise the APC groups, the relative payment weights, and the wage and other adjustments described in section 1833(t)(2) of the Act to consider changes in medical practice, changes in technology, the addition of new services, new cost data, and other relevant information and factors