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FDA Advisory Committee Convenes on Peptides This Week, Understanding What Reclassification Mean Why the regulatory shift makes physician oversight and laboratory-guided prescribing more important, not less We are in the interval between the old rule and the new one

6-8 A few epidemiologic studies have also found a correlation between increased hemoglobin levels and increased vaso-occlusive crisis (VOC) frequency, 9,10 and a phase 3 study of senicapoc (ICA-17043) was stopped early due to lack of efficacy in terms of reduction of VOCs despite an observed increase in hemoglobin and decrease in hemolysis

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(PubMed) Lam-Tse WK, Batstra MR, Koeleman BP, et al

Medical oversight helps ensure appropriate evaluation, dosing discussions, and monitoring, while addressing safety and regulatory considerations.