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."
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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.