Regulators act against firm in human experimenting

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WASHINGTON — Citing serious violations uncovered by a congressional investigation, federal regulators imposed restrictions Tuesday on a company that monitors testing of experimental drugs and medical devices on human beings.

WASHINGTON — Citing serious violations uncovered by a congressional investigation, federal regulators imposed restrictions Tuesday on a company that monitors testing of experimental drugs and medical devices on human beings.

The Food and Drug Administration sent a warning letter to Coast IRB, saying regulators identified "serious violations" of federal rules that protect human subjects and are concerned about risks to patients.

The Colorado Springs, Colorado company agreed to stop reviewing new experiments and also halt enrollment in research trials already under way.

Independent, expert review of clinical trials is an integral part of the development of new drugs, but a congressional hearing last month exposed flaws in the system. Undercover investigators for the Government Accountability Office were able to get Coast IRB’s approval for a fictitious testing protocol that supposedly involved pouring a liter of a product into a woman’s stomach after surgery.

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