FDA Issues Pediatric Drug Labeling Guidelines

Law360, New York (February 27, 2013, 7:26 PM EST) -- The U.S. Food and Drug Administration on Tuesday released draft guidelines on including information about pediatric uses on prescription drug labels, both for drugs that have a pediatric indication and those that don't.

“The goal of this guidance is to help ensure that all useful information on the use of drugs and biological products in the pediatric population (whether positive, negative or inconclusive) is consistently placed in the proper sections within labeling so that the information is clear and accessible to health care providers,” the FDA...
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