Combination products : regulatory challenges and successful product developement - Gopalaswamy, Smita; Gopalaswamy, Venky (Boca Raton : CRC Press, 2008)
Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges
Keywords: Equipment Design -- standards -- United States; Pharmaceutical Preparations -- standards -- United States; Biological Products -- standards -- United States; Device Approval -- standards -- United States; Equipment and Supplies -- standards -- United States