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

• المؤلفون الرئيسيون: Russie Tran (مؤلف), Grace Fraser (مؤلف), Adam C. Fisher (مؤلف), Sau L. Lee (مؤلف), Ashley Boam (مؤلف), Stelios Tsinontides (مؤلف), Jennifer Maguire (مؤلف), Lawrence X. Yu (مؤلف), Susan Rosencrance (مؤلف), Steven Kozlowski (مؤلف), Don Henry (مؤلف)
• التنسيق: كتاب
• منشور في: Elsevier, 2024-06-01T00:00:00Z.
• الموضوعات: article
• الوصول للمادة أونلاين: 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...