PEDIATRICS Vol. 95 No. 3 March 1995, pp. 349
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FDA TO MAKE IT EASIER FOR DRUG MAKERS TO GIVE PEDIATRIC-DOSE DATA TO DOCTORS

J. F. L. MD

The Food and Drug Administration plans to make it easier for pharmaceutical manufacturers to provide doctors with information on the proper doses of prescription drugs for children.

FDA Commissioner David Kessler is expected to announce plans today to allow manufacturers in some circumstances to provide pediatric-use information on drug labels, even if they haven't held full-blown clinical trials involving children. The information would be based on extrapolations from adult studies, plus other data about the effects on children.