Templates – DCP (AR/Comments) · D70 Preliminary AR and D120 Draft AR

D70 Preliminary AR         D70 Overview AR Template (empty) (May 2022)         Overview AR Template (including instructions) (January 2024)         Quality (January 2017)         Non-clinical (October 2016)         Clinical (January 2017) D100 CMS Comments (April 2023) D105 clock stop (March 2012) Applicant’s response template (September 2023) D120 Draft AR         Non-clinical (October 2016)         Clinical (October 2016) D120/D180 Quality AR (December 2018) D145 CMS comments (April 2023) D205 CMS Comments (April 2023)