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2274. 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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):
Government Regulation
Immune Checkpoint Inhibitors -- administration & dosage
Immune Checkpoint Inhibitors -- pharmacokinetics
Programmed Cell Death 1 Receptor -- administration & dosage
United States
United States. Food and Drug Administration

2277. 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

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2022
Subject(s):
Government Regulation
Medical Device Legislation
Terminology as Topic
United States
United States. Food and Drug Administration
United States.

2279. How increased funding can advance the mission of the Indian Health Service to improve health outcomes for American Indians and Alaska Natives

Publication:
Washington, D.C. : Office of the Assistant Secretary for Planning and Evaluation, Office of Health Policy, July 2022
Subject(s):
American Indian or Alaska Native -- statistics & numerical data
Financing, Government
Health Status Disparities
Healthcare Disparities
Outcome Assessment, Health Care
United States
United States. Indian Health Service.