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

Review Of Reviews: Drug Review Profiles Of 2011

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

You may also be interested in...



FDA Plays Nicely: Fibrocell Laviv Review Drew From Three Centers

Fibrocell’s autologous cell therapy Laviv was reviewed by CBER with significant help from CDER and CDRH, providing a model of how FDA can handle high-tech products that cross traditional boundaries.

Missing Mechanism Of Action Dogged Laviv Review

Absence of data about what happens under the surface of the skin when the cell therapy for wrinkles is injected raised safety concerns.

Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval

FDA approved Bristol-Myer’s Squibb’s metastatic melanoma immunotherapy Yervoy (ipilimumab) only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS004897

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