FDA Proposes Generic Drug Label Updates Without Preapproval
The Food and Drug Administration is proposing to allow generic drug and biological product manufacturers to update safety labels without preapproval from FDA, in a move that would give generic drug companies the same flexibility as their brand-name counterparts. FDA’s proposed rule (here) would allow certain temporary labeling changes upon submission of a “changes being effected” document. FDA would then make a decision after the fact on whether to approve the labeling change. If approved, the change would also apply to the corresponding brand drug label, FDA said. Comments on the proposal are due by Jan. 13.
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Currently, generic drug manufacturers have to wait until the corresponding brand-name product has been approved to update product safety information on labels, said FDA in a press release (here). Applications to change labels on generics have to wait until FDA and the brand drug manufacturer have decided on the updated labeling. Brand-name manufacturers, on the other hand, are able to update their labels without preapproval by submitting a “changes being effected” document. FDA’s proposed rule “would speed the dissemination of new safety information about generic drugs to health professionals and patents by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling,” FDA said.