Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.
Document Type
Article
Publication Date
3-1-2020
Publication Title
The oncologist
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number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling.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.
Volume
25
Issue
3
First Page
405
Last Page
411
Recommended Citation
Balogh EP, Bindman AB, Eckhardt SG, Halabi S, Harvey RD, Jaiyesimi I, Miksad R, Moses HL, Nass SJ, Schilsky RL, Sun S, Torrente JM, Warren KE. Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs. Oncologist. 2020 Mar;25(3):e405-e411. doi: 10.1634/theoncologist.2019-0698. Epub 2019 Dec 8. PMID: 32162805; PMCID: PMC7066705.
DOI
10.1634/theoncologist.2019-0698
ISSN
1549-490X
PubMed ID
32162805