Pink Sheet 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

CDER reorganization

This article was originally published in The Tan Sheet

Executive Summary

Center for Drug Evaluation & Research Director Stephen Galson announces he will appoint a new associate center director "to focus on broad drug safety policy and safety communication" as part of the planned reorganization of the center in a staff memo Nov. 4. The memo provides an update to the proposed CDER reorganization that Galson announced Oct. 19 in conjunction with the appointment of a new Office of Drug Safety head. "Consolidating certain drug safety-related activities to report to this new associate center director" was also suggested by Galson in the update. In addition to drug safety goals, Galson hopes CDER will embrace the Critical Path Initiative and "improve regulatory and drug development science." His suggestions include creating a new office that will report to the center director and "provide a locus in the center to catalyze Critical Path activities." In the memo, Galson announces the appointment of Paul Seligman, MD, to associate center director...

You may also be interested in...



FDA Drug Safety Bulletin Being Considered To “Streamline” Communication

Implementation of an FDA standard drug safety bulletin will be one area of focus for the agency's new Associate Director for Safety Policy & Communication Paul Seligman

P&G Health, Hygiene Brands Ride Consumer ‘Trust’ To Sales Growth Amid Pandemic Uncertainty

“There’s a heightened need for products that deliver against health, hygiene and clean home concerns and a willingness to spend just a little bit more to ensure that I’m using a product that I know and trust,” says CFO Jon Moeller 

Asia Deal Watch: Rhizen Licenses Chinese Rights For PI3K Inhibitor To Curon

Curon thinks tenalisib can offer a differentiated and safe new therapy for hematologic cancers such as multiple forms of lymphoma. Axis and PharmaEssentia team up on TCR therapy R&D in Taiwan.

Topics

UsernamePublicRestriction

Register

OM013057

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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