Whether you’re still filing IND submissions in paper, or have filed electronically for a while, you’ll value this just-published book from FDAnews. Author William Sietsema, drawing on his real-world experience with IND submissions — and adding real-world case studies from ZymoGenetics and Epix — offers ready-to-use, expert guidance on the content and structure of all the components of an IND in CTD format with the focus on electronic submissions.
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Preparation and Maintenance of the IND Application in eCTD Format is available in print for $497 each.
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