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’s Drug Integrity Program Gains Formal Role In Compliance Office Reorg

Executive Summary

FDA’s nascent Drug Integrity and Security Program gains an enhanced and more formal role with the reorganization and elevation of the Center for Drug Evaluation and Research’s Office of Compliance to “super-office” status.

You may also be interested in...



CDER’s New Compliance Director Sklamberg Brings Experience On Compounding Issues

Howard Sklamberg, deputy associate commissioner in FDA’s Office of Regulatory Affairs, will take over as director of the Center for Drug Evaluation and Research’s Compliance Office in January; acting compliance director Ilisa Bernstein will resume her role as deputy director.

Generic Drugs Gain Status Boost Within CDER

More than just a bureaucratic shell game, the promotion of the Office of Generic Drugs to “super office” status signals CDER Director Janet Woodcock’s tightened focus on generic drugs.

FDA's Office of Medical Policy Grows Into A "Super Office"; DDMAC Gets A Promotion

The Office of Medical Policy now houses the Office of Prescription Drug Promotion (formerly DDMAC) and the newly created Office of Medical Policy Initiatives.

Related Content

Topics

UsernamePublicRestriction

Register

OM001644

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