Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes
This article was originally published in The Tan Sheet
Executive Summary
Pediatric OTC acetaminophen product labels should include directions for children under 2 years and as young as 6 months and instructions for dosing by weight, a panel of advisors told FDA.
You may also be interested in...
Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda
Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.
Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda
Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.
CHPA Agenda 2014: Monograph Reform, NSURE Progress
The Consumer Healthcare Products Association plans to tackle big tasks in 2014, including working with FDA to improve the monograph system, move the new Rx-to-OTC switch paradigm forward and determine quality metrics to help FDA better target inspections. The trade group also is looking for ways to ease pricing pressures and ensure quality does not suffer.