---

---

---

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

This webinar will:

• Provide an overview of draft guidance for industry entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content
• Present a discussion of draft guidance for industry entitled Providing Over-the-Counter Monograph Submissions in Electronic Format
• Enable participants to gain a general understanding of the content provided in both guidance documents

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals involved in the development or marketing of nonprescription drugs (NDAs, ANDAs, OTC monographs).
• Consultants focused on developing or marketing nonprescription drug products
• Foreign regulators following the development or marketing of nonprescription drug products
• General public with an interest in nonprescription drug products
• Industry involved in the development of nonprescription drug products

TOPICS COVERED

• FDA’s recommendations on the format and content of the information that requestors should provide in an (OTC) monograph order request (OMOR)
• The information that FDA may recommend for a sufficiently complete OMOR
• Examples of OTC monograph submissions that must be in electronic format
• FDA’s recommendations and other information on how to send OTC monograph submissions to FDA in electronic format

FDA SPEAKERS | PANELISTS

OTC Monograph Reform: OMOR Format and Content & Electronic Submissions

Laverdis Davis, MD
Medical Officer
Division of Nonprescription Drugs II | Office of Nonprescription Drugs (ONPD)
Office of New Drugs (OND) | CDER | FDA

CDR Danielle Terrell (Smith), PharmD, JD, MS
Associate Director for Strategic Initiatives
ONPD | OND | CDER | FDA

FDA RESOURCES

• Over-the-Counter Monograph Order Request: Format and Content draft guidance
• Providing Over-the-Counter Monograph Submissions in Electronic Format draft guidance
• CDER NextGen Portal
• OTC Monographs@FDA Portal
• FDA’s Electronic Drug Registration and Listing System (eDRLS)

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, the attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are available only during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.