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Webcast

Event Title
OTC Monograph Reform in the CARES Act: Safety Orders
January 27, 2021


Date:
January 27, 2021
Time:
1:00 PM - 2:00 PM ET


This webinar will provide an overview of nonprescription drugs, Over-the-Counter (OTC) Monograph Reform, and how FDA identifies and evaluates safety issues.  The webinar will also explain the procedure for FDA-initiated administrative orders to address safety issues and how the public can participate in the administrative order process.

TOPICS 

  • Nonprescription drugs and Over-the-Counter (OTC) Monograph Reform
  • FDA’s identification, evaluation and response to safety issues.  
  • Procedure and timeline for FDA-initiated administrative orders to address safety issues
  • OTC Monographs@FDA and comment submission

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

LEARNING OBJECTIVES

  • Provide an overview of nonprescription drugs 
  • Provide an overview of Over-the-Counter (OTC) Monograph Reform
  • Discuss how FDA identifies, evaluates, and responds to safety issues 
  • Provide an overview of FDA-initiated administrative orders to address safety issues
  • Provide an overview of OTC Monographs@FDA and comment submission

FDA SPEAKERS

Valerie Pratt, MD
Deputy Director for Safety
Division of Nonprescription Drugs I | Office of Nonprescription Drugs | CDER | FDA

Evelyn Mentari, MD, MS
Acting Deputy Director for Safety
Division of Nonprescription Drugs II | Office of Nonprescription Drugs | CDER | FDA

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

  • has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.
  • has been 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.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

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