Pediatric labeling

In an October 27 public hearing on FDA's proposed regulation on mandatory pediatric labeling for drugs and biologics, the American Academy of Pediatrics (AAP) recommended the formation of a pediatric drug labeling advisory panel to determine, among other things, which drugs really need to be studied.

Use of an advisory panel that represents the interests of both the medical community and drug manufacturers may alleviate or minimize the concerns of both sides, said the AAP spokesperson. At the same hearing, an executive of pharmaceutical giant Merck Research Labs said it is critical to prioritize the need for labeling of drugs already on the market. He said FDA, AAP and other pediatric groups should identify compounds most in need of pediatric study and labeling.

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