This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citing articles on HighWire  • Citing articles on Web of Science (5)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in JAMA  Topic Collections  • Drug Therapy  • Adverse Effects  • Alert me on articles by topic  Social Bookmarking   What's this?

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

To the Editor: The Research on Adverse Drug Events and Reports (RADAR) project described in the Special Communication by Dr Bennett and colleagues¹ shows how a focused research team can aid postmarketing surveillance by actively investigating potential adverse drug reactions (ADRs). Operating out of a National Cancer Institute–designated comprehensive cancer center, the RADAR project is well-configured to address cancer and hematopoietic-related ADRs, an important category of adverse events often associated with drug exposures. Other organ-based specialists, such as hepatologists involved with the Drug Induced Liver Injury Network,² similarly offer insights into drug-related illnesses of patients in their care.

The workup of suspect adverse events described for the RADAR project is very similar to the recent description by a public advisory committee of the activities of US Food and Drug Administration (FDA) safety evaluators.³ Safety review in the FDA is also highly systematic and involves primary, secondary, and tertiary clinical review . . . [Full Text of this Article]

Anne E. Trontell, MD, MPH
trontella@cder.fda.gov
Office of Drug Safety
FDA Center for Drug Evaluation and Research
Rockville, Md

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLES

The RADAR Project and the FDA—Reply
Charles L. Bennett, Jonathan R. Nebeker, and Dennis W. Raisch
JAMA. 2005;294(10):1206-1207.
EXTRACT | FULL TEXT  

The Research on Adverse Drug Events and Reports (RADAR) Project
Charles L. Bennett, Jonathan R. Nebeker, E. Allison Lyons, Matthew H. Samore, Marc D. Feldman, June M. McKoy, Kenneth R. Carson, Steven M. Belknap, Steven M. Trifilio, Glen T. Schumock, Paul R. Yarnold, Charles J. Davidson, Andrew M. Evens, Timothy M. Kuzel, Jorge P. Parada, Denis Cournoyer, Dennis P. West, Oliver Sartor, Martin S. Tallman, and Dennis W. Raisch
JAMA. 2005;293(17):2131-2140.
ABSTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Evaluation of Serious Adverse Drug Reactions: A Proactive Pharmacovigilance Program (RADAR) vs Safety Activities Conducted by the Food and Drug Administration and Pharmaceutical Manufacturers
Bennett et al.
Arch Intern Med 2007;167:1041-1049.
ABSTRACT | FULL TEXT