Drug Registration (US Market-ANDA, NDA)

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Drug Registration in US Market

Prepared by Docthub Courses Team ∣

Last updated on 03 Feb 2025

Overview

Drug Registration in the US Market involves processes like ANDA (Abbreviated New Drug Application) and NDA (New Drug Application). It falls under pharmaceutical regulatory affairs. The course typically lasts a few months to a year. It covers the regulatory framework for drug approval, including FDA guidelines, application processes, and compliance requirements. Participants learn about filing requirements, safety and efficacy data, and post-market surveillance.

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Institute of Good Manufacturing Practices (IGMPI), New Delhi

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Regulatory Affairs Officer

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Qualifications

MPharm Regulatory Affairs

DPharm (Diploma in Pharmacy)

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Related Specialty

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