HBW Insight 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


FDA Citizen Petition Proposal Inhibits OTC Drug Review Process - CTFA

This article was originally published in The Rose Sheet

Executive Summary

An FDA proposal to ban citizen petitions on pending regulations "appears to preclude the introduction of new data and information in the OTC drug review," the Cosmetic, Toiletry and Fragrance Association argues in Feb. 28 comments.

You may also be interested in...

OTC Drug Labeling Implementation Date Extended One Year To 2002

FDA is extending the OTC drug labeling implementation date to May 2002 to allow time for the agency to develop "forthcoming guidances" regarding a number of outstanding concerns from trade organizations.

Citizen Petitions May Not Preempt Agency Action Under FDA Proposed Rule

Pending FDA actions cannot be the subject of a "citizen petition" submitted to the agency, a proposed rule published in the Nov. 30 Federal Register directs.

FDA Extends Sunscreen Monograph Implementation Date To December 2002

FDA will delay the effective date of the OTC sunscreen final monograph a year-and-a-half, following a request from the Cosmetic, Toiletry and Fragrance Association, the agency says in an Oct. 1 letter to the trade group.

Related Content




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