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

FDA Biologics Center Performance To Be Reviewed By Advisory Committees

This article was originally published in The Pink Sheet Daily

Executive Summary

Center for Biologics Evaluation & Research expects the review to take place within the year. CDER Office of Drug Evaluation VI's continued use of CBER facilities will likely be part of that review.

You may also be interested in...



FDA Oncology Therapeutics Office Planned; Drug, Biologics Units To Be Merged

The agency is understood to be finalizing a plan that would complete the integration of the oncology review teams as originally intended under the CDER/CBER consolidation. Oncology Drug Products Division Director Richard Pazdur, MD, and ODE VI Director Karen Weiss, MD, are potential candidates to head the merged cancer office.

Barr’s Expanded Thalidomide ANDA Could Increase Likelihood Of A Marketed Generic

Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.

User Fee Deal For Ad Review Funds Stems From PhRMA DTC Principles

A draft agreement between industry and FDA that would assess user fees for "advisory review" of broadcast direct-to-consumer ads prior to initial public dissemination had its genesis in the Pharmaceutical Research & Manufacturers of America's DTC guiding principles

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS059678

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