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Implementing the Common Technical Document (CTD) Format for NDA Submissions
Interactive Elements
Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.The following is one of several interactive elements incorporated in Implementing the Common Technical Document (CTD) Format for NDA Submissions. Refer to the course agenda on pages 4 and 5 for additional examples.
Convert a New Drug Application to the CTD Format
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Our company has just licensed a new product
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The company that we licensed from filed an NDA to FDA about 1.5 years ago and received a "not approvable" letter
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We are planning to conduct one additional clinical study and will re-file the NDA in CTD format
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Following the detailed discussion of each CTD module, the relevant sections of the NDA table of contents will be mapped to our CTD
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