The accelerated approval pathway in oncology: Balancing the benefits and potential harms.
Author:
Publisher
Elsevier BV
Subject
Health Policy,Oncology
Reference10 articles.
1. Food and Drug Administration, Accelerated Approval, 2018, 〈https://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm〉 (accessed 3 April 2019).
2. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review;Beaver;JAMA Oncol.,2018
3. A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology;Haslam;Eur. J. Cancer,2019
4. Patient perspectives of value of delayed disease progression on imaging (imaging PFS). A treatment trade-off experiment;Robinson;J. Cancer Policy,2021
5. The US Food and Drug Administration’s Approval of Adjuvant Sunitinib for Renal Cell Cancer: A Case of Regulatory Capture?;Gyawali;JAMA Oncol.,2018
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