Nov 30, 2020  
2013-2014 University Catalog 
    
2013-2014 University Catalog [ARCHIVED CATALOG]

BW 708 - Regulatory Writing: New Drug Applications


This course concentrates on the development of clear, concise, consistent, and complete New Drug Application (NDA) reports, focusing on the clinical study report (CSR). It covers the interface between clinical documents and draft package inserts; resources for preparing the CSR; and practice writing a synopsis, table explanations, narrative summaries, and labeling.

Prerequisites & Notes
(Prerequisites: BW 703, BW 704, and BW 705, or permission of program director)

Credits: 3