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


CDER reorganization

This article was originally published in The Tan Sheet

Executive Summary

Office of Postmarketing Drug Risk Assessment and Office of Biostatistics would be transferred out of Office of Review Management and report directly to CDER Deputy Director Steven Galson, MD, under proposal floated by CDER Director Janet Woodcock, MD, in May 15 memo to staff. ORM would still report to Woodcock and contain ODEs I-V, but would be renamed Office of New Drugs to "more accurately and simply reflect its primary function." ORM has grown from overseeing two drug evaluation offices in 1994 to its current five drug offices, OPDRA and OB





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