Kapdi, M., M. Zaveri, Z. Patel, N. Kanaki, P. Donga, and V. Movaliya. “Decoding FDA Complete Response Letters: Regulatory Challenges and Strategies for Successful Drug Approval”. International Journal of Drug Regulatory Affairs, Vol. 14, no. 3, Sept. 2026, pp. 61-67, doi:10.22270/ijdra.v14i3.892.