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  4. OTC Monograph Reform: OMOR Format and Content & Electronic Submissions - 08/22/2023
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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:
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

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

This webinar will:

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


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