NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

Abstract

The NDA Day concept is a unique, new process developed by the Food and Drug Administration (FDA) to expedite tertiary review of New Drug Applications (NDAs). NDA Day for DIPRIVAN® (an intravenous anesthetic), designed to facilitate timely NDA review, took the form of a combined NDA Day/Advisory Committee Meeting—the first time an NDA Day was open to the public. Preparation for the NDA Day/Advisory Committee Meeting included writing synopses of over 60 clinical studies and updating reports on safety. To make ICI personnel easily accessible for additional information needed by the FDA and the Advisory Committee during NDA Day, telecommunications and computer links were established between the FDA offices in Rockville, Maryland and ICI Research Centers in both the United States and the United Kingdom. This paper is an account of ICI Pharmaceuticals Group's planning and preparation leading to FDA approval of DIPRIVAN®, which was granted just 32 days after the NDA Day/Advisory Committee Meeting.