FDA Quality Grades Could Leave Drugmakers Smarting

Law360, New York (October 4, 2013, 6:34 PM EDT) -- The U.S. Food and Drug Administration's evolving plan to score drugmakers' manufacturing quality will be tricky to pull off because while it may reduce drug shortages linked to production errors, it could also backfire by creating pariah companies unable to sell their wares, experts say.

Richard L. Friedman, an associate director in the FDA's Center for Drug Evaluation and Research, confirmed this week that regulators are exploring how they can conduct "better quality assessment of product performance," likening the idea to Consumer Reports magazine.

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