10 years of FDA experience in rare disease and orphan drug pharmaceutical development. Providing consultation and expertise in the following areas: Rare pediatric disease priority review vouchers Requests for rare pediatric disease designation Navigating the steps to getting a voucher NDA or BLA submissions to get a voucher Orphan designation requests Formal meetings with the FDA Pre-IND meeting requests Contents of a meeting background package Interacting with the FDA review divisions Drug development Patient reported outcome (PRO) development Endpoints Regulatory strategy Use of expedited programs (fast track, accelerated approval, breakthrough therapy, priority review)