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 Quality Assurance Unit To Conduct Workshops, Educational Sessions

This article was originally published in The Tan Sheet

Executive Summary

The new Quality Assurance Unit in FDA's Center for Drug Evaluation & Research will be called upon to hold internal workshops and educational sessions to highlight well-conducted drug reviews and to update CDER medical officers on review "best practices."

You may also be interested in...



CDER Review Overhaul Will Include Input From Foreign Reviewers

FDA's Center for Drug Evaluation & Research will invite input from foreign drug regulators as part of a planned revamping of its NDA review process, CDER Director Janet Woodcock, MD, indicated at a seminar for center staff Sept. 15.

CDER Review Overhaul Will Include Input From Foreign Reviewers

FDA's Center for Drug Evaluation & Research will invite input from foreign drug regulators as part of a planned revamping of its NDA review process, CDER Director Janet Woodcock, MD, indicated at a seminar for center staff Sept. 15.

CDER Review Overhaul Will Include Input From Foreign Reviewers

FDA's Center for Drug Evaluation & Research will invite input from foreign drug regulators as part of a planned revamping of its NDA review process, CDER Director Janet Woodcock, MD, indicated at a seminar for center staff Sept. 15.

Topics

UsernamePublicRestriction

Register

OM008605

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