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 Quality Assurance Unit

Executive Summary

Center for Drug Evaluation & Research quality assurance head James Bilstad, MD, will retire from the agency effective Dec. 31. Bilstad, previously director of CDER's Office of Drug Evaluation II, moved to the QA unit in April, due to potential conflicts of interest following the appointment of his wife, Cheryl Graham, MD, as VP-U.S. regulatory affairs at Pfizer (1"The Pink Sheet" April 26, p. 4) Bilstad joined the agency in 1974

You may also be interested in...



FDA Pulmonary Division Director Jenkins To Head ODE II; Bilstad To Head QA

FDA Pulmonary Drug Products Division Director John Jenkins, MD, has been selected to head FDA's Office of Drug Evaluation II, beginning April 25.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Latest Headlines
See All
UsernamePublicRestriction

Register

PS034957

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