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Ucm074980 Form

Ucm074980 Form

Use a content and format of investigational new drug applications inds for phase 1 studies of drugs template to make your document workflow more streamlined.

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so hello everyone and thank you so much for joining me for today's class today we are going to look into a formal meetings between the FDA and sponsors or applicants of a prescription drug and of course we are going to look into this guidance document for the industry which is already posted on FDA website okay so first of all why we are having our class today the the the emphasis is mainly on the I D I would say pre meeting uh still I'm going to go over all of the formal meetings that we may have with FDA because it's not just pre or before starting to apply for the authorization from FDA to conduct a clinical trial on the US soil but we also have other types of meetings like pr- NDA or pre new drug application meeting we may have meetings in order to go over different types of issues that we may encounter we may have meetings that are online meetings that are only for I would say uh we of course we don't record them but we are going to again discuss ab

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