Madhukar, Nishant, Drashti Patel, Krunal Kothari, Smit Nayak, and Saumil Shah. “Regulatory Strategies for Global Approval of Biologic–Medical Device Combination Products: FDA, EMA, and International Perspectives”. Journal of Biomedical and Pharmaceutical Research 13, no. 2 (April 30, 2024): 72–105. Accessed June 23, 2026. https://jbpr.in/index.php/jbpr/article/view/1490.