Introduction to FDA's initiatives to support the new era of the submission and assessment  KASA PQ/CMC
简介FDA的做法 (结合 KASA 与 PQ/CMC的申报)
• Opportunities and challenges in KASA and PQ/CMC projects for biological products 机会与挑战
• General development approach for KASA modules for biotechnology products 生物制品KASA模块的开发