Generic Labeling Rule: Will Delay Spell Doom?

FDA aims to finalize proposed reg that would allow ANDA holders to unilaterally make safety labeling changes by July 2016, but opposition continues to swirl.

FDA appears to have a new goal for finalizing the proposed generic labeling rule, although questions likely still remain as to whether it actually will be implemented.

The White House Office of Management and Budget updated its regulation tracker to indicate that the rule is expected to be finalized in July 2016

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