In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

An FDA Nominee, Biologics Reviews Move to CDER

Executive Summary

The FDA's recent announcement that the responsibility for reviewing biologics would be transferred from the Center for Biological Research (CBER) to the Center for Drug Evaluation and Research came amidst growing industry and congressional criticism about CBER's handling of Biologics Licensing Applications (BLAs). But the FDA's failure to spell out the details of the reorganization leaves many questions unanswered, among them: what will be the implications for biogenerics; how will CBER's funding be affected; and what will be the impact on pending BLAs?

You may also be interested in...



McClellan, Wall Street and Increasing FDA Predictability

The most encouraging aspect of the series of speeches the FDA's new commissioner, Mark McClellan, MD, PhD, has been giving is not what he says--we've heard most of this before--but to whom he says it: pharmaceutical investors and companies.

Our Top Ten Items from a Year Most Want to Forget

From the bear market, to the growing management credibility gap, to GPO whistleblowers, 2002 was a year most of us are glad to have behind us. But within the gloom, some glimmers of hope: most important among them is a sense of directionality at athe FDA following the appointment of a new commissioner.

Biogenerics Are Coming and They're Not the Generics We Know

Biotech and would-be biogenerics companies are battling to shape the future of generic biologics. The FDA, along with established biotech and drug companies, has opposed the concept of biogenerics, insisting the compounds are too complex to be reproducible in a reliable fashion. Challengers insist that the science is advanced enough to make such products feasible and are pumping significant time and money into bringing them to market.

Related Content

Topics

UsernamePublicRestriction

Register

LL1123738

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