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

UsernamePublicRestriction

Off-Label Audience Of One: Exhibit Booths Should Aim For Personal Conversations

This article was originally published in The Pink Sheet Daily

Executive Summary

When responding to an unsolicited request for information on an off-label use of a drug at a medical conference, it’s important that firms ensure only the person who asked the question receives the answer, compliance experts suggest.

You may also be interested in...



Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says

FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.

ASCO advertising letters continue

FDA ad division letters cites Aventis for Taxotere (docetaxel) promotional brochure describing an unapproved indication and SkyePharma/Chiron for solicitation of off-label information requests for DepoCyt at the American Society of Clinical Oncology meeting in May. FDA has issued at least 11 letters regarding promotions at the meeting (1"The Pink Sheet" Aug. 6, p. 6)

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074181

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

Cancel