RGA 6207 NEU BAXDELA Electronic Common Technical Document Essay
Writing Assignment #2 RGA 6207 Electronic Common Technical Document (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 […]
RGA 6207 Reverse Translation Baxdela Writing Project
In completing Writing Assignment #1 for RGA6207 students will have the opportunity to “reverse translate” an FDA approved product insert and other documentation associated with approval of a pharmaceutical or biologic product back to the information submitted by the manufacturer in Module 1 of an eCTD submission. As discussed during Week 3 of the course, […]
