Writing Assignment #2RGA6207 FDA and the Electronic Common Technical Document(eCTD)In completing Writing Assignment #2 for RGA6207 students will have the opportunity to buildupon the research conducted, as well as the foundational knowledge developed in WritingAssignment #1. Thus, to complete Writing Assignment #2 please utilize the FDA approvedpharmaceutical or biologic product selected in Writing Assignment #1. For Writing Assignment#2 please conduct an analysis of the types of background information and data that would berequired in Modules 2 & 3 of a Common Technical Document (CTD) compliant submission toFDA. We have studied the content requirements for CTD Modules 2 & 3 during Weeks 4 & 5 ofthe course.In addition to providing a summary of the content required in Modules 2 & 3 for yourspecifically chosen FDA approved product, your completed Writing Assignment #2 should alsoinclude 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 bythe 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 CTDModule 3• Identification and brief summary of any efficacy and/or safety associatedchallenges/issues that were likely incorporated by the product manufacturer in CTDModule 2As with Writing Assignment #1, your completed Writing Assignment #2 submission should becomprised of 4-6 pages of content (not including references). Writing Assignment #2 is due at11:59 p.m. Eastern Standard Time at the end of Week 6. Please submit your completedassignment through the Turnitin link provided in the Week 6 Module of Canvas. Submissions emailed to the instructor will not be accepted. Please remember that this assignment is worth15.0% of your final grade for the course. Late submissions will not be accepted without priorpermission of the Instructor.
