Reinforcing the social compromise of accelerated approval
Author:
Publisher
Springer Science and Business Media LLC
Subject
Oncology
Link
http://www.nature.com/articles/s41571-018-0066-3.pdf
Reference8 articles.
1. Beaver, J. A. et al. A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics: a review. JAMA Oncol. 4, 849–856 (2018).
2. Kesselheim, A. S. et al. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ 351, h4633 (2015).
3. Naci, H., Smalley, K. R. & Kesselheim, A. S. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration. JAMA 318, 626–636 (2017).
4. Zettler, M. & Nabhan, C. Fulfillment of postmarketing requirements to the FDA for therapies granted oncology indications between 2011 and 2016. JAMA Oncol. https://doi.org/10.1001/jamaoncol.2018.0610 (2018).
5. FDA. Postmarket requirements and commitments database. FDA https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm (2018).
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