Group Seeks Faster Label Updates For Generics Makers

Law360, New York (August 29, 2011, 2:20 PM EDT) -- A consumer group asked the U.S. Food and Drug Administration on Monday to allow generic drug makers to more quickly change their product labels to disclose previously unknown safety risks, citing a recent U.S. Supreme Court ruling related to the issue.

Public Citizen asked the FDA in a petition to pare back regulations that bar generic makers from updating warnings on drug labels without the agency’s approval, even if they discover risks not mentioned in the labeling — a restriction that brand-name drug makers don’t face....
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