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FDA: Generics Rule 'Complicated,' But Not About Litigation

This article was originally published in Scrip

Executive Summary

The FDA's reasons for proposing a rule that would permit generic drug makers to independently revise their product labeling to add new safety updates before regulators review or approve such changes – just like brand-name manufacturers already do – are "complicated," declared Stephen Ostroff, who up until last week had been serving as the agency's acting commissioner for much of the past year.