Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety

Affiliations

Editorial

Nicole M Kuderer et al. J Clin Oncol. 2018.

. 2018 Jun 20;36(18):1773-1776.

doi: 10.1200/JCO.2018.78.5592. Epub 2018 May 9.

¹ Nicole M. Kuderer, Advanced Cancer Research Group, Seattle, WA; and Gary H. Lyman, Fred Hutchinson Cancer Research Center, Seattle, WA.

No abstract available

Comment on

Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials.
Shepshelovich D, Tibau A, Goldvaser H, Molto C, Ocana A, Seruga B, Amir E. Shepshelovich D, et al. J Clin Oncol. 2018 Jun 20;36(18):1798-1804. doi: 10.1200/JCO.2017.77.5593. Epub 2018 Apr 11. J Clin Oncol. 2018. PMID: 29641296
Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Hwang TJ, et al. J Clin Oncol. 2018 Jun 20;36(18):1805-1812. doi: 10.1200/JCO.2017.77.1592. Epub 2018 Apr 24. J Clin Oncol. 2018. PMID: 29688832