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


CDER seeks director

This article was originally published in The Tan Sheet

Executive Summary

FDA is seeking a director for its Center for Drug Evaluation and Research following the October departure of Steven Galson, the agency announces Dec. 3. Accepting applications through Feb. 1, FDA is seeking a candidate who will lead the agency in defining "drug regulatory policy for the next generation," and expediting review of applications for new drug applications, among other goals, FDA notes. Former CDER director Janet Woodcock is filling the role on a temporary basis...

You may also be interested in...

Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss

Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains committed to its historic bargain with the drug industry to take user fees in order to improve application review, but it is finding it increasingly hard to meet deadlines or to perform any other outside projects

CDER director

Janet Woodcock is named director of the Center for Drug Evaluation and Research, where she has served as acting director for six months, the agency says March 10. She previously served as FDA's chief medical officer and as a deputy commissioner. An internist and rheumatologist, Woodcock has held other leadership positions at FDA, including Office of Therapeutics Research and Review director and Center for Biologics Evaluation and Research acting deputy director as well as previous service as CDER director (1"The Tan Sheet" Dec. 10, 2007, In Brief). The Safety First program CDER launched this month is one initiative Woodcock has led since becoming acting CDER director (2"The Tan Sheet" March 3, 2008, p. 9). She also led the agency's launch of the Critical Path Initiative, designed to bridge the gap between basic scientific research and the medical product development process...

FDA “Safety First” Initiative, Agency’s Requests Draw Doubts From DeLauro

FDA is implementing the Safety First initiative to "ensure that significant post-market safety issues are our highest priority," according to acting Center for Drug Evaluation and Research Director Janet Woodcock


Latest Headlines
See All



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