OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
- Provision Consulting Group
- Mar 7, 2022
- 1 min read
Updated: Mar 7, 2022
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During this webinar, FDA will provide an overview of the recently published draft guidance for industry titled Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs.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Overview of the formal monograph meetings draft guidance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
If you have any questions about FDA regulation of NDA
(New Drug Application), Clinical studies... , please CONTACT US.
Office 1-909-493-3276
Email ask@provisionfda.com