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September 2021

The FDA Drug Approval Process

September 20 - September 21

During this course, you will gain a deep understanding of the eCTD submission process for FDA drug approval. This program covers procedures for submission of INDs, NDAs, ANDAs, and 505(b)(2). It provides a useful insight into the organization and structure of the FDA and its review processes and highlights recent changes. The course is well structured and organized in 8 modules which helps the audience to understand the entire drug approval process in a continuous flow. Module 1: History and…

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