Quality and NPK focuses on utilizing prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review. It focuses on concepts for this acceleration especially as related to advanced manufacturing, continuous manufacturing and sterile drug products. Additionally, this focus group is exploring partnering with NIH to address drug shortages and manufacturing in the US.
See Hussain, Gurvich, and Morris, AAPS Pharm Sci Tech, 20:140 (2019)