In addition to providing a summary of the content required in Modules 2 & 3 for...

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In addition to providing a summary of the content required in Modules 2 & 3 for your specifically chosen FDA approved product, your completed Writing Assignment #2 should also include the following: An explanation for whether the Integrated Summaries of Safety (ISS) and Effectiveness (ISE) for your product would be included in CTD Module 2 or Module 5 A description of the non-clinical and clinical information that was likely incorporated by the product manufacturer in CTD Module 2 Identification and synopsis of any Chemistry, Manufacturing and Controls (CMC) challenges/issues that were likely incorporated by the product manufacturer in CTD Module 3 In addition to providing a summary of the content required in Modules 2 & 3 for your specifically chosen FDA approved product, your completed Writing Assignment #2 should also include the following: An explanation for whether the Integrated Summaries of Safety (ISS) and Effectiveness (ISE) for your product would be included in CTD Module 2 or Module 5 A description of the non-clinical and clinical information that was likely incorporated by the product manufacturer in CTD Module 2 Identification and synopsis of any Chemistry, Manufacturing and Controls (CMC) challenges/issues that were likely incorporated by the product manufacturer in CTD Module 3