FDA getting tougher with industry:
This article was originally published in Clinica
Executive Summary
An additional sign that the FDA is stepping up its enforcement action against medical device companies emerged last week. One major Washington law firm, Hogan & Hartson, is currently working on three criminal cases brought by FDA investigators against device firms. At one time, the firm saw only one criminal case every four to five years, partner Jonathan Kahan told the Association of Medical Diagnostic Manufacturers last week. The first inkling that the FDA was getting tough with industry came in late 1999 when the agency won a consent order against Abbott Laboratories for the company's repeated quality systems violations.
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