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Assessment of Regulatory Requirements and Filling Procedure of Drug Master File for Brazil, Europe, and India, USA and Australia

M.N. Shankarananda*1, K. Sunil Kumar2 1Department of DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. 2Associate Professor, Department of DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. A B S T R A C T For a new drug, the FDA commits to reviewing most NDAs/BLAs within a total of ... Read More »

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