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

• मुख्य लेखकों: Russie Tran (लेखक), Grace Fraser (लेखक), Adam C. Fisher (लेखक), Sau L. Lee (लेखक), Ashley Boam (लेखक), Stelios Tsinontides (लेखक), Jennifer Maguire (लेखक), Lawrence X. Yu (लेखक), Susan Rosencrance (लेखक), Steven Kozlowski (लेखक), Don Henry (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: Elsevier, 2024-06-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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...