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


FDAAA and labeling

Executive Summary

Former FDAer Greg Burkhart, Burkhart & Freiman, proposes that one aspect of newfound authority that FDA will embrace is the ability to mandate product labeling changes. "You're going to see something a little bit different regarding how safety information may get into the label. There is going to a much bigger push I think coming from certain parts of the agency. It's going to be very difficult for the divisions ... to resist such changes," he said at the DIA session. Disagreements within FDA over the appropriate treatment of safety information have recently been exposed to the public (1"The Pink Sheet" Aug. 6, 2007, p. 6). "It will change the way that the sponsors are notified when FDA thinks something is going on. Before it had to have a high threshold before FDA would even bother because a lot of times there would be a fight. I don't think that is going to be the case anymore. I think things are going to get into the label now from the FDA viewpoint that may have a lower threshold"...

You may also be interested in...

CDER Offices Go Public With “Fundamental Disagreement” Over Avandia

Political pressure from FDA outsiders interested in improving drug safety oversight may have backfired, resulting in an embarrassing advisory committee meeting for the agency. The July 30 review of a cardiovascular safety signal for GlaxoSmithKline's diabetes drug Avandia became a forum to play out another controversy between the Office of New Drugs and the Office of Surveillance and Epidemiology

US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month

Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.

Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings

More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.

Latest Headlines
See All



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