The Pediatric Exclusivity Form

Instructions and help about The Pediatric Exclusivity

thank you for that introduction good day everyone for the next 15 minutes we're going to be talking about pediatric exclusivity i note that this presentation reflects my views and shouldn't be construed to represent fda's views or policies so over the next coming slides we're going to be discussing the bpca the best pharmaceuticals for children act which created the pediatric exclusivity construct we're going to talk about the basics of what it is and how it works we're going to talk about ppsrs and written requests the sponsor side and the fda side of developing pediatric studies we'll be discussing the requirements for sponsors to fairly respond to an fda generated written request if they want exclusivity and at the end i'll provide some resources some challenge questions and a recap overview of the 10 000 foot level of the process and components of pediatric exclusivity so pediatric exclusivity what is it basically like other exclusivities it is a financial incentive for sponsors an