Virtual | Virtual
Event Title
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
August 22, 2023
- Date:
- August 22, 2023
- Time:
- 1:00 p.m. - 2:00 p.m. ET
Topic & Presentation |
Speakers |
---|---|
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions |
|
OTC Monograph Reform Guidances: |
Laverdis Davis, MD |
Q&A Discussion Panel |
Laverdis Davis and CDR Danielle Terrell (Smith), PharmD, JD, MS |
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- Provide an overview of draft guidance for industry entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content
- Present a discussion of draft guidance for industry entitled Providing Over-the-Counter Monograph Submissions in Electronic Format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- Over-the-Counter Monograph Order Request: Format and Content draft guidance
- Providing Over-the-Counter Monograph Submissions in Electronic Format draft guidance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)
Event Materials
Title | File Type/Size |
---|---|
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions_August-22-2023.pdf | pdf (2.35 MB) |