NEWS - Drug study reviewer halted on safey issue

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Wall Street Journal

15 Apr 2009

By ALICIA MUNDY

Drug-Study Reviewer Halted on Safety Issue

A Colorado company caught in a congressional sting operation involving

oversight of patient safety during clinical trials will voluntarily

halt many of its review operations at the request of the Food and Drug

Administration, the FDA said Tuesday.

The company, Coast IRB LLC of Colorado Springs, Colo., approves

clinical-trial designs and patient-safety guidelines. Companies and

medical institutions are required to have an independent institutional

review board, or IRB, give these approvals when they experiment on

human subjects.

The stoppage could affect 300 trials involving more than 3,000

researchers and includes work for several major pharmaceutical,

biotechnology and medical-device companies, according to the FDA. Many

of these companies would have to hire an IRB to replace Coast.

Ball, director of scientific-investigations compliance in the

FDA's drug division, said the agency asked Coast to stop some aspects

of its reviews " due to serious concerns the FDA has about Coast's

ability to protect human subjects. "

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http://online.wsj.com/article/SB123973801498717895.html

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