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


In Brief: FDA OTC label study

This article was originally published in The Tan Sheet

Executive Summary

FDA OTC label study: Data summarizing results of the agency's "Over-the-Counter Label Format Preference" study, also known as Study B, are expected to be published in the Federal Register the week of Dec. 22. Planned for 900 participants, the mall-intercept study examined perceptions of different label designs for cough/cold and sunscreen products. Participants were asked to "evaluate labeling terminology and graphics to investigate how they interpret various ways of communicating drug safety and effectiveness," FDA says in a notice summary. Comments on the data will be accepted for 45 days from the date of publication. FDA announced its intention to conduct Study B and a related 1,200-subject study in its Feb. 27 proposed rule on OTC label reform; the agency described plans for the studies in May ("The Tan Sheet" May 26, p. 1)...

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





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