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US FDA finalises "changes being effected" labelling rule

This article was originally published in Scrip

Executive Summary

The US FDAhas finalised a controversial rule clarifying the types of drug and biological labelling changes that can be made through a "changes being effected" (CBE) supplement without prior agency approval. The timing of the final measure, just seven months after the proposed rule was released, seems to be aimed at bolstering the government and industry in a closely watched drug labelling pre-emption case that will be argued before the Supreme Court on November 3rd.



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