OTC Monograph Reform: OMOR Format and Content & Electronic Submissions August 22, 2023

Virtual | Virtual

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• Date: August 22, 2023
• Time: 1:00 PM - 2:00 PM ET

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Topic & Presentation	Speakers
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
OTC Monograph Reform Guidances: 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
Q&A Discussion Panel	Laverdis Davis and CDR Danielle Terrell (Smith), PharmD, JD, MS Associate Director for Strategic Initiatives ONPD | OND | CDER | FDA

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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• Provide an overview of draft guidance for industry entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content
• Present a discussion of draft guidance for industry entitled Providing Over-the-Counter Monograph Submissions in Electronic Format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)

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Event Materials

Title	File Type/Size
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions_August-22-2023.pdf	pdf (2.35 MB)