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

CBER/CDER Transition Begins In June: Application Assignments “99.99%” Set

Executive Summary

The reorganization of the Center for Biologics Evaluation & Research and Center for Drug Evaluation & Research is scheduled to take effect on June 30 with the detailing of approximately 200 employees from CBER to CDER

You may also be interested in...



Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

CDER Office Of Biotech Products To Oversee Biologics Quality After Transition

Center for Drug Evaluation & Research Office of New Drug Chemistry Director Yuan-yuan Chiu, PhD, will serve as acting director of FDA's Office of Biotech Products when the office is officially established in October

Generic Biologics On FDA Fast Track?: “Follow-On” Process Under Debate

Data requirements for generic biologics approved under the 505(b)(2) process will be taken up by FDA over the next six months, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS041465

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