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2155. Pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer: guidance for industry

2158. Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff

2160. How increased funding can advance the mission of the Indian Health Service to improve health outcomes for American Indians and Alaska Natives