This review conducts a comparative analysis of drug approval for new and generic medicines across three jurisdictions: United States (US FDA), India (CDSCO), and the European Union (EMA) framed as a three-stage process (application, review, approval) and focusing on regulatory pathways, statutory timelines, documentati...
Suchita Anand Shirole, Syed Shoaib Ali· International Journal of Dru...· 0 citations
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