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In nuclear medicine, the development and application of anti-CD38 conjugates with radionuclides represent significant advances in the diagnosis and treatment of MM, offering more precise, personalized and effective therapeutic strategies

After consideration of public comments, discussed in an earlier section of this final rule with comment period, we are finalizing with modification our proposals to replace the estimated allowed amount with the median allowed amount and to add the 10th and 90th percentile allowed amounts, including our proposed methodology for calculating the allowed amounts should the calculated percentile fall between two observed allowed amounts, effective January 1, 2026

A Certificate of Analysis (CoA) detailing purity, identity, and conformity is available for each batch.