Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory scie

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed b

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory scie

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the sa

Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinica