Putanga 1: Ko te New Molecular Entity (NME) he rongoā kei roto i tētahi wāhanga kaha kāore anō kia whakaaetia e te FDA, kia hokona rānei i te US. Putanga 2: He raau taero hou (NME) he raau taero kei roto he waahanga kaha kaore ano kia whakaaetia e te FDA, kia hokona ranei i te US. Pātai: He ōrite te tikanga o te rerenga 1 me te rerenga 2? He Ae, he Kore rānei?
Āe, āe