Zdrowie i gospodarka · 02/04/2013

FDA Releases Guidance on User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

The Food and Drug Administration (FDA) has made available a guidance document outlining the types of Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs) subject to user fees, as well as those that are exempt, and the refund policies for these submissions.