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Changes Being Effected to Drug Labeling Regime: FDA Releases Proposed Pathway for Generic Safety Updates

by Jonathan Berman
Jones Day - Washington Office

Jennifer J. Chheda
Jones Day - New York Office

Colleen Heisey
Jones Day - Washington Office

December 10, 2013

Previously published on December 2013

On November 13, the U.S. Food and Drug Administration ("FDA") published a proposed rule concerning "procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information prior to FDA's review of the change" that would, specifically, allow abbreviated new drug application ("ANDA") holders to update product labeling for their "generic" drug products in advance of its reference listed drug ("RLD"; i.e., the approved drug product to which the generic version was compared to show bioequivalence). FDA's proposal would permit-for the first time-a generic drug product label to differ from the RLD product label, ostensibly for a limited and temporary time period.


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