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


Testimonials Lead To Overbroad Claims, DDMAC Warning Letter Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Implied efficacy claims from a physician and patients for Testopel testosterone pellets, among many other problems with a series of promotional pieces, draw a warning letter to Slate Pharmaceuticals.

You may also be interested in...

Disease-Awareness Ads Thrive In Regulatory No-Man’s Land

FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?

FDA Cites Gleevec For Promoting Unapproved Indications Three Weeks Before Expanding Label

Notice of violation letter to Novartis from FDA’s Office of Prescription Drug Promotion expresses concern about describing a patient with five-year survival data, a claim that was added to the label the following month.

Don't Be Inspired To Cite Non-Clinical Data Like Clinical Data In Drug Ads, DDMAC Says

Inspire Pharmaceuticals gets a letter from FDA's Division of Drug Marketing, Advertising and Communications for a four-page professional journal ad for its bacterial conjunctivitis treatment AzaSite.

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