《H-Generic-label-LeePresentation》.pdf

Generic Labeling 2007 CDR Koung Lee, RPh, USPHS Labeling Review Branch Division of Labeling Program Support/Office of Generic Drugs Center for Drug Evaluation Research/U.S. Food Drug Administration (240)-276-8981 E-mail koung.lee@ 1 GENERIC LABELING Must be the same as the last approved labeling for the reference listed drug (RLD) except for differences allowed by the regulations. Differences may include different manufactured by statements, expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(4)(D) of the act. Page 2 Labeling Currently in Use Labeling that may be outdated Labeling that may contain revisions that were reported in the annual report Labeling that may include additional safety information that was submitted as changes being effected Page 3 Page 4 Page 5 Final Print Format Page 6 Final Print Format Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 The Electronic Labeling Rule Effective June 8, 2004 Requires that “the content of labeling be submitted electronically in a form that FDA can process, review, and archive”. Page 14 Structured Product Labeling (SPL) Implemented on