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NETS - Health Authorities

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What are health authorities' reporting meeting and amendment procedures, and why are they important in drug development?

In the United States, FDA reporting meetings are conducted after the completion of an IND application but prior to the official ruling on an NDA. They provide the sponsor with the opportunity to discuss their application with regulatory officials and make the necessary updates. Members of the community, including patients, advocates, and researchers, are also allowed to offer their perspective on an investigational compound to regulatory officials.

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