• Provision Consulting Group

OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings

Mar 07 2022


Date:

March 29, 2022


Time:

2:00 PM - 3:00 PM ET



ABOUT THIS WEBINAR


During this webinar, FDA will provide an overview of the recently published draft guidance for industry titled Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs.


FDA will also:

  • Provide an overview of OTC Monograph Reform

  • Explain OMUFA Timelines



TOPICS COVERED


  • Overview of OTC Monograph Reform

  • Overview of the formal monograph meetings draft guidance

  • Meeting types and formats

  • Content and format of meeting requests

  • Meeting request responses, meeting scheduling, and timelines

  • Meeting packages, preliminary responses, and meeting minutes

  • Rescheduling and canceling

  • Procedure for joint meetings

  • OMUFA timelines



INTENDED AUDIENCE


  • General public with an interest in nonprescription (also known as over-the-counter or OTC) drugs

  • Regulatory affairs professionals involved in the development or marketing of OTC drugs

  • Foreign regulators following the development or marketing of OTC drugs

  • Consultants focused on OTC drug development or marketing

  • Clinical research coordinators

  • Importers of OTC drugs

FDA SPEAKER


Trang Tran


Commander, U.S. Public Health Service Senior Regulatory Health Project Manager Division of Nonprescription Drugs 1 Office of New Drugs (OND) Office of Regulatory Operations (ORO) Center for Drug Evaluation and Research (CDER) | US FDA


Elizabeth Thompson

Commander, U.S. Public Health Service Chief, Project Management Staff Division of Nonprescription Drugs 2 OND | ORO CDER | US FDA




FDA RESOURCES


OTC Monograph Reform in the CARES Act

OTC Monographs@FDA

Over-the-Counter OTC/Nonprescription DrugsGuidances



https://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-reform-overview-draft-guidance-formal-meetings#event-information




If you have any questions about FDA regulation of NDA

(New Drug Application), Clinical studies... , please CONTACT US.


Office 1-909-493-3276

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