Before revision: A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1) International agreementsThe HPFB signed an electronic data interchange agreement with the US Food and Drug Administration in November 2003, and again in April 2004 with the Therapeutic Goods Administration of Australia.
After revision: :A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1) International agreementsThe HPFB signed an electronic data interchange agreement with the US Food and Drug Administration in November 2003, and again in April 2004 with the Therapeutic Goods Administration of Australia.