Akebia announced that the company received a second interim response from the FDA to its Formal Dispute Resolution Request, or FDR, regarding the Complete Response Letter for vadadustat received in March 2022. Akebia received notification from the Office of New Drugs, or OND, Center for Drug Evaluation and Research, that due to agency resource constraints and staffing needs the deciding authority for the appeal will now be Peter Stein. The appeal was originally assigned to a senior advisor within the OND.
Published first on TheFly
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