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

To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.

You may also be interested in...



Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.

Regulatory Round-Up: Drug Review Profiles From 2012

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.

Teratogenic Drugs Pose Little Risk To Partners Of Male Patients, FDA Panel Says

There is little to no evidence that a teratogenic drug would pass from a man to his female partner at a high enough level to endanger a fetus, the Drug Safety and Risk Management Advisory Committee tells FDA.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS004974

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