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FDA warns Johnson & Johnson about clinical trial procedures
Physician Practice Advisor, July 21, 2004
The Food and Drug Administration (FDA) posted a letter yesterday warning Johnson & Johnson's Cordis for failing to follow clinical trial procedures for a stent designed to treat clogged arteries in the neck, Reuters reported.
FDA inspectors claim that Cordis didn't ensure that researchers complied fully with the study plan or document deviations properly, and asked Cordis to provide details on the steps it will take to correct the problems.
Cordis spokeswoman Terri Mueller said the letter focused on "procedures, tracking and documentation," and would "impact the conclusion or the credibility of the data," Mueller said.
To read the FDA's warning letter, click here.
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