Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jul 1;4(7):993-994.
doi: 10.1001/jamaoncol.2018.0610.

Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016

Marjorie Zettler  1 , Chadi Nabhan  1
Affiliations

Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016

Marjorie Zettler et al. JAMA Oncol. .

Abstract

This data analysis examines the fulfillment of postmarketing requirements associated with drugs granted accelerated approval for oncology indications in the past 6 years.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Drs Zettler and Nabhan are both employed by Cardinal Health, Inc.

Comment in

References

    1. Jena AB, Zhang J, Lakdawalla DN. The trade-off between speed and safety in drug approvals. JAMA Oncol. 2017;3(11):1465-1466. - PubMed
    1. Woloshin S, Schwartz LM, White B, Moore TJ. The fate of FDA postapproval studies. N Engl J Med. 2017;377(12):1114-1117. - PubMed
    1. US Government Accountability Office DRUG SAFETY: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement (GAO-16-192: Published December 15, 2015. Publicly released January 14, 2016) https://www.gao.gov/products/GAO-16-192. Accessed February 27, 2018.