Varshney, N., V. Bhalla, and M. K. Gupta. “Technical Reasons for Delay and Denial of Regulatory Approval of Initial Applications for (Abbreviated) New Drugs Filed by Indian Companies by USFDA, 2005-2022”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 1, Mar. 2024, pp. 54-60, doi:10.22270/ijdra.v12i1.653.