Data exclusivity, market protection, orphan and paediatric ...

Regulatory consequences of determination of NAS A. If significant differences in safety and/or efficacy ... quantifying risk for each therapy Major contribution to patient care •New mode of administration (e.g. ease of self-administration) •New route of administration

  Data, Protection, Market, Consequences, Quantifying, Orphans, Exclusivity, Data exclusivity, Market protection, Orphan and