TAG ARCHIVES FOR coast IRB

5
May2009

Coast IRB to close

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(Originally posted on the Wall Street Journal online)

Coast IRB said the disclosure of the sting and an April 14 warning letter from the Food and Drug Administration describing the company's violations led several high-profile customers to pull their business. As a result, "Coast IRB's owners decided, through counsel, to cease future company operations," a company statement said.

The company had said earlier that it intended to temporarily halt accepting new business and to stop enrolling patients in studies that had begun while it made a thorough overhaul of its operations.

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21
Apr2009

(Originally posted by the Northwest Association for Biomedical Research)On Tuesday, April 14, officials at the Food and Drug Administration issued a warning letter to Coast IRB in response to their recent approval of a fake device study submitted by the Government Accountability Office. As a result Coast IRB has voluntarily agreed to review no new studies or enroll new subjects into ongoing protocols, both under 21 CFR Part 56.