GPhA is cautious about FDA's approach on generic drug labels

07/8/2013 | Los Angeles Times (tiered subscription model)

The Generic Pharmaceutical Association is wary about the FDA's minimally detailed proposal that could allow or require makers of generics to provide supplemental warnings about increased or new risks before label changes are formally approved. The approach could open the way for lawyers to contend in court that generics were unreasonably risky if they could have had additional warning but didn't, Jon Healey writes. "Our members have a long history of working closely with FDA to ensure that Americans have access to safe, affordable generic medicines, and we look forward to working with FDA on this important issue," GPhA CEO Ralph Neas said.

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