US FDA's proposed changes to generic labeling face fresh criticism

13 April 2016

Further concerns have been expressed at the US Food and Drug Administration proposals for the labeling of generic drugs.

The FDA first put forward its Proposed Rule, which would allow generic companies to independently update safety warnings – something which only brand-name can currently do before receiving regulatory permission - in November 2013.

The agency has faced a major backlash from consumer and industry groups, and has twice delayed the rule’s publication date. The latest planned date for this is July 2016.

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