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DELAYED: FDA Grapples With Generics Labeling Rule

This article was originally published in Scrip

Executive Summary

The FDA came under fire, but also got some praise, on Dec. 3 for again delaying a rule it initially had promised to finalize in December 2014 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.