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


Actual Use, Label Comprehension Guidances Slated For 2006

This article was originally published in The Tan Sheet

Executive Summary

Guidances under development in 2006 reflect FDA's interest in improving the quality of Rx-to-OTC switch submissions

You may also be interested in...

FDA Clearance May Thwart Monograph Goal; Ganley Talks Turkey About ONP

The Office of Nonprescription Products' goal of completing all OTC monographs by 2010 is viable only if FDA improves its document clearance process, according to ONP head Charles Ganley, MD

NDAC Calls For Predefined Endpoints In Consumer Behavior Trials

Rx-to-OTC switch sponsors will be expected to work with FDA to establish predefined endpoints for each consumer behavior trial they plan, if the agency follows advice given by the Nonprescription Drugs Advisory Committee during a Sept. 25 meeting

NDAC Meeting On Actual-Use Trials Scheduled For September

FDA's Nonprescription Drugs Advisory Committee will convene Sept. 25 to "consider issues related to the analysis and interpretation of consumer behavior studies conducted to support marketing" of OTCs

Related Content





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