Tracking User Fee Invoices, Payments and Cover Sheet Details The FDA’s user fee programs, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Amendments (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Amendments (MDUFA), are critical in facilitating the review process for drug and device approvals. This tutorial provides a comprehensive guide to tracking user fee invoices, payments, and related cover sheet details essential for pharmaceutical professionals, clinical operations, regulatory affairs, and medical affairs. In meeting FDA expectations, understanding these requirements is paramount in ensuring compliance with the user fee acts….