Скачать с ютуб OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration в хорошем качестве

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration

This webinar provided 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. Discussions included the registration process for over-the-counter monograph drug facilities, the different fee types for OMUFA, fiscal year 2024 target revenue, fee rates, and timelines as well as the penalties associated with failure to pay OMUFA user fees. And lastly, OMUFA refund eligibility. Timestamps 02:37 – What is OMUFA? 06:47 – Registration and Listing 09:29 – OMUFA User Fee Types and FY 2024 Key Dates 13:12 – COVID-19 Hand Sanitizer Manufacturers 17:21 – What is OMOR? 22:39 – Fee Payment Process 24:10 – Penalties for Failure to Pay Fees 25:22 – Refund Eligibility 30:27 – Q&A Discussion Panel Speakers: LCDR Tramara Dam, Pharm.D., MBA, BCSCP, GWCPM Senior Program Management Officer Division of User Fee Management (DUFM) Policy and Operations Branch (POB) Office of Management (OM) Center for Drug Evaluation and Research (CDER) | FDA LCDR Yajun (Jason) Tu, Pharm.D., Ph.D., BCSCP Program Management Officer DUFM | POB | OM | CDER | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367