Top
US_Flag An official website of the United States government Here's how you know
GOV

The .gov means it's official.

Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

LOCK

The site is secure.

The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

 
U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
CDER Small Business and Industry Assistance 1 Hour Web Series: OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
August 22, 2023


Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Series Description

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.

Lecture Description
FDA will provide an overview of the draft guidance's for industry entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content and also the draft guidance Providing Over-the-Counter Monograph Submissions in Electronic Format. Participants will gain a general understanding of the content provided in both guidance documents.
References
  • Over-the-Counter Monograph Order Request: Format and Content draft guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/over-counter-monograph-order-requests-format-and-content
  • Providing Over-the-Counter Monograph Submissions in Electronic Format draft guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-over-counter-monograph-submissions-electronic-format
  • CDER NextGen Portal https://edm.fda.gov/
  • OTC Monographs@FDA Portal https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm
  • FDA’s Electronic Drug Registration and Listing System (eDRLS): https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drugregistration-and-listing-instructions
Series Objectives
  • Demonstrate the ability to solve FDA drug regulatory issues as they arise.
  • Explain new FDA regulatory initiatives.
Learning Objectives After completion of this activity, the participant will be able to:
  • Discuss the FDA recommendations related to the format and content that should be provided in an (OTC) monograph order request (OMOR)
  • Give examples of OTC monograph submissions that must be in electronic format
  • Outline the best practices for FDAs OTC monograph submissions in electronic format
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda

Lecture 1 August 22, 2023
Time Topic Speaker
1:00 - 2:00 PM EDT OTC Monograph Reform: OMOR Format and Content & Electronic Submissions Danielle Terrell, PharmD, JD, MS
Laverdis Davis, MD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-008-L99-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

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.

Important Note regarding completion of evaluations and receiving credit
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.
Disclosure

Faculty
  • Davis, Laverdis, MD, Physician Medical Officer, FDA - nothing to disclose
  • Terrell, Danielle, PharmD, JD, MS, Associate Director for Strategic Initiatives, 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
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.