FDA Finalizes Blood Donor Eligibility Guidance

blood donation

On May 11, 2023, the U.S. Food and Drug Administration released final guidance providing recommendations for evaluating blood and plasma donor eligibility using individual risk-based questions. Consistent with FDA’s January 2023 proposed guidance, the final guidance eliminates time-based donation deferrals and screening questions specific to men who have sex with men (MSM) and women who have […]

FDA issues response to Novo Nordisk’s request for concizumab approval

Recently Novo Nordisk received a Complete Response Letter from the Food and Drug Administration for concizumab. Concizumab was submitted for regulatory approval in the U.S. for the treatment of hemophilia A and B with inhibitors in August 2022. In the letter, the FDA requested additional information related to the monitoring and dosing of patients to […]