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Syed Shoaib Ali

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Review Open access Sep 2026

Comparative Study of Regulatory Requirement and Approval Process for Drugs in India, US and Europe

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 · 0 citations

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