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 New Quality Office Still Awaiting Final Sign Offs

This article was originally published in RPM Report

Executive Summary

FDA’s proposed Office of Pharmaceutical Quality remains a personal and professional priority of CDER Director Janet Woodcock, and she determined to get the office up and running before the end of the fiscal year.

You may also be interested in...



CDER Office of Pharmaceutical Quality Launches; Initial Impact On Manufacturers Is Minimal

FDA completed a major reorganization of the way it regulates manufacturing quality of drugs and biologics with the launch of the Office of Pharmaceutical Quality within the Center for Drugs. OPQ is part of Janet Woodcock’s decade-long effort to ensure a consistent, safe drug supply. The immediate impact on industry will be minimal, but manufacturers that haven’t invested in facility upgrades will face a steep learning curve.

CDER Office of Product Quality Ready To Go: New Structure Sends Strong Signal To Industry

It took a while, but the Office of Pharmaceutical Quality is finally ready to begin operations. Biopharma companies should recognize the declaration of FDA’s priorities, and respond accordingly.

Expanded Access Theme Is One Sour Note For Biopharma In “21st Century Cure” Roundtable

The Energy & Commerce Committee “21st Century Cures” Process promises to set a pro-innovation tone heading into the next user fee reauthorization cycle. There is one theme, however, that may be perilous for industry moving forward: Expanded Access.

Related Content

Topics

UsernamePublicRestriction

Register

PS079718

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