HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

“No End In Sight” For Completing OTC Monographs – CDER Director Woodcock

This article was originally published in The Tan Sheet

Executive Summary

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...



FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure

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 Petitions For Acetaminophen Under-2 Dose Labeling

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 Call For Pediatric Cough/Cold Input Signals New Rule Is A Long Way Off

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

Topics

Latest News
See All
UsernamePublicRestriction

Register

RS139332

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel