A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions

A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

Published:2012-11 Issue:6 Volume:8 Page:e158-e167
ISSN:1554-7477
Container-title:Journal of Oncology Practice
language:en
Short-container-title:JOP

Author:

Chen Brian¹,Restaino John¹,Norris LeAnn¹,Xirasagar Sudha¹,Qureshi Zaina P.¹,McKoy June M.¹,Lopez Isaac S.,Trenery Alyssa,Murday Alanna¹,Kahn Adam¹,Mattison Donald R.¹,Ray Paul¹,Sartor Oliver¹,Bennett Charles L.¹

Affiliation:

1. University of South Carolina, Arnold School of Public Health; South Carolina College of Pharmacy, Columbia; Medical University of South Carolina, Charleston, SC; Northwestern University Feinberg School of Medicine, Chicago, IL; Risk Sciences International, Ottawa, Canada; and Tulane University School of Medicine, New Orleans, LA

Abstract

The authors reviewed FDA and manufacturer responses to a citizen petition filed to address thalidomide safety issues and concluded that new approaches addressing off-label safety are needed.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Health Policy,Oncology (nursing),Oncology

Link

http://ascopubs.org/doi/pdfdirect/10.1200/JOP.2011.000504

Reference24 articles.

1. Protecting the Health of the Public — Institute of Medicine Recommendations on Drug Safety

2. DP Carpenter: Reputation and the organizational politics of new drug review, in Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 2010 Princeton, NJ Princeton University Press

3. THALIDOMIDE AND CONGENITAL ABNORMALITIES

4. Thalidomide in the treatment of lepra reactions

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Translating Research into Health Policy: The Citizen Petition Experience with the Food and Drug Administration;Cancer Drug Safety and Public Health Policy;2022

2. Thalidomide, Drug Safety, and Off-label Prescribing;JAMA Oncology;2018-07-01

3. Fluoroquinolone-related neuropsychiatric and mitochondrial toxicity: a collaborative investigation by scientists and members of a social network;The Journal of Community and Supportive Oncology;2016-02

4. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR);Seminars in Thrombosis and Hemostasis;2012-10-21