Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
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...



Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

Hatch Closing Act: OTC Monograph Reform Legislation?

The Utah Republican has been instrumental during his more than 40 years in office in passing legislation central to the growth of the OTC drug and dietary supplement industries. But the expansion of the OTC market is stifled by FDA's monograph system for making more ingredients available, a process agency officials say no longer works.

'Not As Easy' OTC Codeine Label Changes Worry FDA Rx Product Advisors

FDA officials acknowledge at the Pediatric Advisory Committee Sept. 11 that labeling restrictions for opioid-containing Rx antitussives for pediatric cough wouldn't apply to labeling for codeine cough products available under an OTC monograph.

Related Content

Topics

UsernamePublicRestriction

Register

PS106814

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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