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

• Main Authors: Russie Tran (Author), Grace Fraser (Author), Adam C. Fisher (Author), Sau L. Lee (Author), Ashley Boam (Author), Stelios Tsinontides (Author), Jennifer Maguire (Author), Lawrence X. Yu (Author), Susan Rosencrance (Author), Steven Kozlowski (Author), Don Henry (Author)
• Format: Book
• Published: Elsevier, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 assess...