Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

Autor: Balogh EP; Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA., Bindman AB; University of California, San Francisco, California, USA., Eckhardt SG; University of Texas at Austin's Dell Medical School, Austin, Texas, USA., Halabi S; Duke University, Durham, North Carolina, USA., Harvey RD; Emory University, Atlanta, Georgia, USA., Jaiyesimi I; Beaumont Hospital, Royal Oak, Michigan, USA., Miksad R; Flatiron Health, New York, New York, USA., Moses HL; Vanderbilt University, Nashville, Tennessee, USA., Nass SJ; Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA., Schilsky RL; American Society of Clinical Oncology, Alexandria, Virginia, USA., Sun S; Janssen Research and Development, Raritan, New Jersey, USA., Torrente JM; Hyman, Phelps & McNamara, P.C., Washington, DC, USA., Warren KE; Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: The oncologist [Oncologist] 2020 Mar; Vol. 25 (3), pp. e405-e411. Date of Electronic Publication: 2019 Dec 08.
DOI: 10.1634/theoncologist.2019-0698
Abstrakt: A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.
(© 2019 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.)
Databáze: MEDLINE
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