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FDA proposal could speed safety information updates on generic drugs
A proposal would allow faster dissemination of new safety information about generic drugs to health professionals and patients, according to a press release from the U.S. Food and Drug Administration.Currently, generic manufacturers must wait to update product safety information until the corresponding brand-name product has received approval to update its safety information. Under the proposed rule, generic drug manufacturers would be able to independently update product labeling with newly acquired safety information before the FDA’s review of the change, similar to the current process for brand-name drugs, the release said.