Generic Drug Labeling
2014-04-04T21:54:23-04:00https://ximage.c-spanvideo.org/eyJidWNrZXQiOiJwaWN0dXJlcy5jLXNwYW52aWRlby5vcmciLCJrZXkiOiJGaWxlc1wvMjAzXC8yMDE0MDQwNDIyMTEyMTAwM19oZC5qcGciLCJlZGl0cyI6eyJyZXNpemUiOnsiZml0IjoiY292ZXIiLCJoZWlnaHQiOjUwNn19fQ==Witnesses testified at a hearing on the Food and Drug Administration’s FDA’s proposal to have generic drug makers update their safety labels as soon as the information becomes available. At the time of this hearing, generic brands could not update labels unless the original developer did so. Some lawmakers expressed concern that the rule change could create contradictory labels for the same medicine. FDA official in charge of drug evaluation and research Janet Woodcock testified the first panel. In a separate panel, the subcommittee also heard from the president of the Generic Pharmaceutical Association.
Witnesses testified at a hearing on the Food and Drug Administration’s FDA’s proposal to have generic drug makers update their safety… read more
Witnesses testified at a hearing on the Food and Drug Administration’s FDA’s proposal to have generic drug makers update their safety labels as soon as the information becomes available. At the time of this hearing, generic brands could not update labels unless the original developer did so. Some lawmakers expressed concern that the rule change could create contradictory labels for the same medicine. FDA official in charge of drug evaluation and research Janet Woodcock testified the first panel. In a separate panel, the subcommittee also heard from the president of the Generic Pharmaceutical Association. close
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Michael Shumsky Attorney
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Janet Woodcock M.D. Director U.S. Food and Drug Administration->Center for Drug Evaluation and Research
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