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

UsernamePublicRestriction

In Switch Label Studies, FDA Carefully Reads Data On Low-Literacy Consumers

This article was originally published in The Tan Sheet

Executive Summary

Switch sponsors should include low-literacy subjects in label comprehension studies to address the “real risk” of taking an Rx product OTC, says a CDER Division of Nonprescription Drug Products social scientist. Self-selection studies similarly should include at-risk consumer populations.

You may also be interested in...



Pfizer Lipitor OTC Bid Would Face FDA Evolving On Switch Innovation

Pfizer looks to lessons from prior statin attempts and an environment open to new ways to inform consumer decisions as it considers filing for a Lipitor switch, which will depend on the outcome of a large actual use trial.

FDA Self-Selection Study Guidance Calls For Complex Questions

Final guidance on Rx-to-OTC self-selection studies makes space for investigation of novel switches under NSURE by recommending researchers ask complex questions that “involve a higher level of understanding” of multiple label elements at once.

Label Comprehension Guidance May Improve Switch Outlook

Final guidance for label comprehension studies replaces several draconian draft recommendations with more flexible "common sense" measures, but drug sponsors may need to conduct significantly larger, more expensive studies and meet more extensively with the agency, experts say

Topics

UsernamePublicRestriction

Register

RS123629

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