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Pediatric labeling

This article was originally published in The Tan Sheet

Executive Summary

NDMA requests "feedback" meeting to discuss agenda of the scheduled Sept. 11 meeting of FDA's Nonprescription Drugs Advisory Committee. FDA has announced the group will discuss pediatric labeling of OTC combo cough/cold products ("The Tan Sheet" March 2, p. 5); NDMA asks to be informed of issues and "specific questions" that will be covered at the meeting, and seeks info on what topics were not "adequately addressed" at the committee's previous two meetings to discuss pediatric labeling ("The Tan Sheet" Sept. 18, 1997, pp. 1-3 and Jan. 16, 1995, p. 10). The association also inquires whether the agenda will be "limited to consideration of cough/cold ingredients under the OTC review." The recent announcement of the committee's September 1997 meeting "was an example of industry being given very limited time to respond," NDMA says, noting the reason for early publication of the committee's agenda is "so interested parties are given sufficient time to develop useful input for the committee"...

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