FDA's Generic-Drug Plan Will Live Or Die On Sameness Rule

Law360, New York (July 8, 2013, 10:07 PM EDT) -- Though the U.S. Food and Drug Administration plans to allow generic-drug makers to change their warning labels, the agency's authority to do so will depend on finding wiggle room in the requirement that generic and brand-name labels match, experts say.

The U.S. Department of Health and Human Services indicated Wednesday that it expected to issue a notice of proposed rulemaking for the labeling rule change by September. Under current regulations, generics makers must match a drug's labeling to its brand-name counterpart, a requirement that has protected...
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