FDA rule would allow generic drugmakers to update labels

Agency plans to issue new rule by September

The Food and Drug Administration (FDA) plans to issue a new rule that will allow generic drugmakers to make changes to their drugs’ labeling.

Federal law dictates that generic drug labels must be identical to their brand-name counterparts’ labels. Currently, generic manufacturers aren’t allowed to update their drug labels even if they learn of a potential safety issue that isn’t included on the existing label.

Ashley Post

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