Apr 22, 2021  
2019-2020 University Catalog 
2019-2020 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