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

FDA Phone Call Preceded Untitled Letter To Lilly Over Amyvid

This article was originally published in The Pink Sheet Daily

Executive Summary

Lilly promised to remove offending images from promotional materials for its imaging product, but the agency followed up with a “notice of violation” letter two months later anyway.

You may also be interested in...



FDA Warns King Of Warning Letter: Firm Got Head Start On Fixing Embeda Ads

FDA's early intervention regarding misleading advertisements for King's morphine product Embeda gave the company a head start on reviewing its promotional pieces, but it did not mean the company could escape from the official warning letter

FDA Response Time For DTC Ad Advisory Comments Has Doubled, Agency Says

FDA has increased from two to four weeks the time it takes to return direct-to-consumer broadcast ads with advisory comments due to the enlarged volume of submissions, Division of Drug Marketing, Advertising & Communications Branch Chief Nancy Ostrove, PhD, reported Sept. 13 at a Food & Drug Law Institute conference on "Marketing and Promotion in the New Millennium."

Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.

Topics

Related Companies

UsernamePublicRestriction

Register

PS074681

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