🔹 ABOUT THIS EVENT 

This webinar will provide an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describes the key elements of the program as it relates to OMUFA user fees. Presentations will cover:

• The OMUFA draft guidance for industry “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program."
• An update for facilities that first registered with FDA on or after the declaration of the COVID-19 PHE for the sole purpose of producing hand sanitizer products during the COVID-19 PHE

🔹 TOPICS COVERED

• Registration for over-the-counter monograph drug facilities
• The different fee types for OMUFA and the the fee payment process
• Fiscal year 2024 target revenue, fee rates, and timelines
• More...

🔹 AND DON'T FORGET

• Subscribe to CDER SBIA industry updates to keep current with information vital to the pharma industry.
• Explore our CDER SBIA Learn Online Training Repository. Feel free to share this resource with friends and colleagues.

🔹 INTENDED AUDIENCE

Those working on, specializing in, or interested in learning more about over-the-counter (OTC) monograph drug products and/or non-prescription drugs, including:

• Regulatory affairs professionals, U.S. and foreign
• Industry partners following the FDA’s implementation of  OMUFA
• Researchers and clinical research coordinators
• More...