The European Medicines Agency is to fine tune its initiative for offering early scientific advice to support the development of pediatric medicines, after a two-year pilot of the scheme found that three quarters of applications for early advice were out of scope.
Only nine of the 36 requests from companies that applied to take part in the pilot phase, which ran from June 2015 and March 2017, were accepted, while the remaining 27 were considered to be out of scope because the products were already at advanced stages of development, a spokesperson for the EMA told the Pink Sheet