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Listen "Navigating the ANDA Process: A Comprehensive Guide"
Episode Synopsis
In this conversation, Anne and Nu Trelle from Compliance Insight Inc. discuss the Abbreviated New Drug Application (ANDA) process, which allows for the approval of generic drugs in the US. They explore the history of ANDAs, the requirements for filing, the significance of bioequivalence studies, and the importance of the Chemistry, Manufacturing, and Controls (CMC) section. The discussion also covers the FDA review process, timelines, and post-approval steps necessary for bringing a generic drug to market.
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