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Start Over Subjects United States ✖Remove constraint Subjects: United States Subjects United States. Food and Drug Administration ✖Remove constraint Subjects: United States. Food and Drug Administration Languages English ✖Remove constraint Languages: English Copyright Public domain ✖Remove constraint Copyright: Public domain

1. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

6. 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

9. 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.

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