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OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings

Tuesday, March 29, 2022

2:00 p.m. - 3:00 p.m. (Eastern - UTC-05:00)

This webinar is FREE

 

During this webinar, FDA will provide an overview of the recently published draft guidance for industry titled "Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs."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  • Overview of the formal monograph meetings draft guidance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

 

FDA SPEAKERS

 

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

 

 

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  • 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
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PLEASE NOTE that the app to print your certificate of attendance will become available at the end of the event and will only be available for 2 weeks after the event.

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R E S O U R C E S

C O N T I N U I N G    E D U C A T I O N    I N F O R M A T I O N

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

 

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