“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock
This article was originally published in The Tan Sheet
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.
You may also be interested in...
Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.
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.
FDA plans to revise monograph language for over-the-counter pediatric cough/cold products, but the agency is seeking input on some basic data questions first, indicating many steps will be taken before a rule can be finalized