RGA6207 Electronic Common TechnicalDocument (eCTD)

In completing Writing Assignment #2 for RGA6207students will have the opportunity to build upon theresearch conducted, as well as the foundationalknowledge developed in Writing Assignment #1. Thus,to complete Writing Assignment #2 please utilize theFDA approved pharmaceutical or biologic productselected in Writing Assignment #1. For WritingAssignment #2 please conduct an analysis of the typesof background information and data that would be required in Modules 2 & 3 of a Common TechnicalDocument (CTD) compliant submission to FDA. Wehave studied the content requirements for CTDModules 2 & 3 during Weeks 4 & 5 of the course.

RGA6207 Electronic Common TechnicalDocument (eCTD)

In addition to providing a summary of the contentrequired in Modules 2 & 3 for your specifically chosenFDA approved product, your completed Writing Assignment #2 should also include the following:

• An explanation for whether the IntegratedSummaries of Safety (ISS) and Effectiveness(ISE) for your product would be included in CTDModule 2 or Module 5

• A description of the non-clinical and clinicalinformation that was likely incorporated by theproduct manufacturer in CTD Module 2

• Identification and synopsis of any Chemistry,Manufacturing and Controls (CMC)challenges/issues that were likely incorporatedby the product manufacturer in CTD Module 3

• Identification and synopsis of any quality associated challenges/issues that were likelyincorporated by the product manufacturer in CTDModule 3