Draft Guidance for Industry and Food and Drug Administration; User Fees and Refunds for Premarket Approval Applications; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "User Fees and Refunds for Premarket Approval Applications" (PMAs). The purpose of this draft guidance document is to outline the types of PMAs subject to user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The draft guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee.