CHPA Petitions For Acetaminophen Under-2 Dose Labeling
This article was originally published in The Tan Sheet
Executive Summary
CHPA urges FDA not to wait until it publishes the final internal analgesics, antipyretic and anti-rheumatic monograph before allowing manufacturers to label acetaminophen products with dosing information for children 6 months to 2 years old. In a citizen petition, the trade group proposes FDA publish a statement of enforcement policy expressly permitting the use of a standardized age- and weigh-based dosing chart.
You may also be interested in...
“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock
Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.
“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock
Janet Woodcock says FDA expected when the process was launched to complete all monographs by the year 2000, but 25 remain in tentative final monograph status, with a rulemaking required to finalize each one. “The rulemaking process … doesn’t work for getting monographs done in a very timely manner,” she says.
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.