A network of regulatory innovations to improve FDA quality assessments of human drug applications

A network of regulatory innovations to improve FDA quality assessments of human drug applications

A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA’s Center for Drug Evaluation and Research (CDER) aims to enhance the quality assessment...

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Bibliographic Details
Main Authors: Russie Tran, Grace Fraser, Adam C. Fisher, Sau L. Lee, Ashley Boam, Stelios Tsinontides, Jennifer Maguire, Lawrence X. Yu, Susan Rosencrance, Steven Kozlowski, Don Henry
Format: Article
Language:English
Published: Elsevier 2024-06-01
Series:International Journal of Pharmaceutics: X
Subjects:
Regulatory innovations
Quality assessments
Pharmaceuticals
Knowledge Management
Structured Data
Online Access:http://www.sciencedirect.com/science/article/pii/S2590156724000112

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