Pink Sheet 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


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...

Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication

US FDA has made efforts to improve health communications to cater to deficiencies in literacy; other specific topics for discussion at the meeting remain unclear.

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.

Related Content


Latest Headlines
See All



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