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US lawmakers explore FDA's decision to keep stent on market

This article was originally published in Clinica

Executive Summary

US lawmakers are investigating whether the Food and Drug Administration (FDA) acted properly when it allowed the Cordis division of Johnson & Johnson to continue selling drug-eluting stents (DESs), following the agency's findings that the company violated multiple manufacturing rules, writes April Fulton. House energy and commerce committee chairman John Dingell and subcommittee on oversight and investigations chairman Bart Stupak, both Michigan Democrats, sent a letter to FDA Commissioner Andrew von Eschenbach on August 13, requesting he turn over all records related to an April 2004 warning letter sent to Cordis and subsequent communications between the company and the agency in the next two weeks.

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