Guidance for Industry and Food and Drug Administration Staff; User Fees and Refunds for Premarket Approval Applications; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "User Fees and Refunds for Premarket Approval Applications." This guidance outlines the types of premarket approval applications (PMAs), including supplements and other submissions, that are subject to user fees as well as those that do not have an associated fee. The guidance also identifies industry and FDA actions on these submissions that may result in a partial refund of the fee. The guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).