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Pharmaceuticals / Regulatory Affairs

FDA Pulls Rule Allowing Independent Updates to Generic Drug Labeling

Dec. 21, 2018
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The FDA withdrew a proposed rule on Thursday that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data.

The FDA proposed the rule in November 2013 but some stakeholders pushed back, claiming the change could create major new burdens and liabilities that could lead to increased costs they would have to pass on to customers.

Stakeholders also argued that the new rule would have led to labels for the same drug temporarily bearing different labeling information between different generics manufacturers, said FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock in announcing the withdrawal of the proposal.

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