May 5, 2026
The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees. Topics to be discussed include:
- Overview of OMUFA as it relates to user fees, fees liable period and due dates
- Registration process for over-the-counter monograph drug facilities
- Different fee types for OMUFA
- Fiscal year 2026 target revenue, fee rates, and timelines
- Penalties associated with failure to pay OMUFA user fees
- Fee payment process.
- OMUFA refund eligibility
- OMUFA frequently asked questions
Intended Audience
- Regulatory affairs professionals working on over-the-counter monograph drug products and/or non-prescription drugs or who submit over-the-counter monograph order requests
- Industry partners following the FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Amendments known as OMUFA
- Researchers and Foreign Regulators testing over-the-counter monograph drug products and/or non-prescription drugs
- Consultants focused on processing, manufacturing, developing of over-the-counter monograph drug products and/or non-prescription drugs
- Clinical research coordinators
- Importers and supply chains of over-the-counter monograph drug products and/or non-prescription drugs
- Healthcare professionals specializing in over-the-counter monograph drug products and/or non-prescription drugs
- General public with an interest in over-the-counter monograph drug products and/or non-prescription drugs
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