Steven Gutman
Food and Drug Administration
7 Papers
117 Citations
Steven Gutman is an academic researcher from Food and Drug Administration. The author has contributed to research in topics: Cancer & Biomarker discovery. The author has an hindex of 4, co-authored 7 publications.
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Papers
Point-of-care biosensor systems for cancer diagnostics/prognostics
Steven A. Soper,Kathlynn C. Brown,Andrew D. Ellington,Bruno Frazier,Guillermo Garcia-Manero,Vincent Gau,Steven Gutman,Daniel F. Hayes,Brenda Korte,James L. Landers,Dale N. Larson,Frances S. Ligler,Arun Majumdar,Marco Mascini,David D. Nolte,Zeev Rosenzweig,Joseph Wang,David F. Wilson +17 more
TL;DR: This review seeks to provide an overview of the current thinking on molecular profiling for diagnosis and prognosis of cancers and provide insight into the current state-of-the-art in the biosensor field and new strategies that must be considered to bring this important technology into the cancer field.
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Translational Crossroads for Biomarkers
Robert C. Bast,Hans Lilja,Nicole Urban,David L. Rimm,Herbert A. Fritsche,Joe W. Gray,Robert W. Veltri,George G. Klee,Andrew R. Allen,Nam Hee Kim,Steven Gutman,Mark A. Rubin,Andrew M. Hruszkewycz +12 more
TL;DR: A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests for cancer care.
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Food and Drug Administration Regulation of in Vitro Diagnostic Devices
TL;DR: The criteria that are used to classify and review in vitro diagnostic devices are described and the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification pathway are discussed.
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Introduction to the Food and Drug Administration (FDA) regulatory process.
Joseph L Hackett,Steven Gutman +1 more
TL;DR: FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of the Medical Device Amendments of 1976, which produced for the first time a menu of laboratory tests on the market.
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