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

Waking Up to REMS: Redefining Marketing (Part 3)

Executive Summary

This feature first appeared in The RPM Report, September 2009 (Also see "Waking Up to REMS (Part 3): Redefining Marketing" - Pink Sheet, 1 Sep, 2009.).

You may also be interested in...



Assessing REMS: Risk Management's Key Question -- Do The Programs Work?

The first stage of REMS implementation from March 2008 until December 2009 was relatively easy. FDA and drug sponsors leaqrned how to adapt existing communications programs and techniques to deliver new safety messages. Now both the agency and the sponsors are moving into new territory: evaluating REMS. Both are grappling with the challenge of how to show that programs are working.

Waking Up to REMS (Part 3): Redefining Marketing

FDA's new post-marketing safety authorities place unprecedented burdens on pharmaceutical marketers. But they do something else: redefine a favorite target of industry critics as a regulatory requirement rather than a suspicious activity.

‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation

CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

IV003245

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