OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees 

FDA provides an overview of the Over-The-Counter Monograph Drug User Fee program (OMUFA) and discusses the registration process for over-the-counter monograph drug facilities, the different fee types for OMUFA, fiscal year 2021 fee rates and timelines, penalties associated with failure to pay OMUFA user fees, an overview of the fee payment process, and OMUFA refund eligibility.
Learn more at: www.fda.gov/dr...
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
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