1. Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs
- Author
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Steven Sun, Andrew B. Bindman, S. Gail Eckhardt, Harold L. Moses, Richard L. Schilsky, Ishmael Jaiyesimi, Josephine M. Torrente, Rebecca A. Miksad, R. Donald Harvey, Susan Halabi, Katherine E. Warren, Sharyl J. Nass, and Erin Balogh
- Subjects
Cancer Research ,Pharmaceutical research ,Oncology and Carcinogenesis ,Pilot Projects ,030226 pharmacology & pharmacy ,Drug prescriptions ,Food and drug administration ,03 medical and health sciences ,0302 clinical medicine ,Rare Diseases ,Neoplasms ,Commentaries ,Drug legislation ,Prescribing information ,Drug approval ,Medicine ,Humans ,Oncology & Carcinogenesis ,Drug Labeling ,Cancer ,Drug labeling ,Medical education ,business.industry ,United States Food and Drug Administration ,United States ,Clinical Practice ,Oncology ,Pharmaceutical Preparations ,030220 oncology & carcinogenesis ,6.1 Pharmaceuticals ,Commentary ,business ,Oncology drugs - Abstract
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number of important drugs used to treat cancer—many of which serve as the backbone of modern chemotherapy regimens—have outdated prescribing information in their drug labeling.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., The U.S. Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for long‐standing oncology drugs. This article highlights a number of considerations for labeling updates.
- Published
- 2019