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

UsernamePublicRestriction
UsernamePublicRestriction

Substantial Changes On "Substantial Evid&nce" Citations By FDA

Executive Summary

FDA's ad division appears to be shifting the focus of its promotional oversight to emphasize problematic comparative claims as opposed to safety concerns, according to an analysis by "The Pink Sheet." All but one of the letters sent in 2006 cited shortcomings in safety presentations (the exception was a letter to Boehringer Ingelheimabout formulary placement claims for Spiriva Handihaler). In contrast, about 71 percent of the letters this year cite safety issues. Although FDA is on track to send approximately the same total number of letters as it did last year, the agency is using "untitled" letters more frequently then it did last year.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS048704

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

Cancel