CDER Small Business and Industry Assistance 1 Hour Web Series: OMUFA FRN and Draft Guidance Webinar
May 16, 2023
FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.
The webinar provides 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.
- Over-The-Counter Monograph User Fee Program (OMUFA) at https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa
- November 2, 2022: OMUFA draft guidance for industry titled “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.” https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-over-counter-monograph-drug-user-fee-program?utm_medium=email&utm_source=govdelivery
- February 1, 2022: OMUFA Draft guidance “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs” https://www.fda.gov/media/155864/download
- Updated Over-the-Counter Monograph User Fee Program Performance Goals Dates– Fiscal Years 2021-2025: https://www.fda.gov/media/146283/download
- OMUFA Cover Sheet and Payment Information: https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp
- An Exciting New Chapter in OTC Drug History: OTC Monograph Reform in the CARES Act at https://www.fda.gov/news-events/fda-voices/exciting-new-chapter-otc-drug-history-otc-monograph-reform-cares-act
- Demonstrate the ability to solve FDA drug regulatory issues as they arise.
- Explain new FDA regulatory initiatives.
- List the fees associated with the Over-the-Counter Monograph Drug User Fee Program (OMUFA)
- Explain the registration process for over-the-counter monograph drug facilities
- Discuss the different fee types for OMUFA
- Describe the fee collection and payment process for OMUFA
This activity is intended for physicians, pharmacists, and nurses.
Lecture 1 May 16, 2023
Time | Topic | Speaker |
---|---|---|
1:00 - 2:00 PM EDT | OMUFA FRN and Draft Guidance Webinar |
Matthew Brancazio, PharmD, MBA, RAC Tramara Dam, PharmD, MBA, BCSCP, GWCPM Yajun Tu, PhD, PharmD, BCSCP |
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Faculty
- Brancazio, Matthew, PharmD, MBA, RAC, Branch Chief, Policy and Operations, Food and Drug Administration - nothing to disclose
- Dam, Tramara, PharmD, MBA, BCSCP, GWCPM, Program Management Officer, FDA/CDER/OM/DUFM - nothing to disclose
- Tu, Yajun, PhD, PharmD, BCSCP, Program Management Officer, FDA - nothing to disclose
Planning Committee
- Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.