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"...
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning