Zdrowie i gospodarka · 03/01/2005
Guidance for Industry on Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees." The guidance describes the agency's current policy on what should be contained in separate marketing applications and what should be combined into one application for purposes of assessing user fees and a definition of "clinical data" for user fee purposes.