- January 27, 2021
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.
- 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
- 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
- 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
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
- Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
- FDA STATEMENT - FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
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.
Please contact firstname.lastname@example.org for all technical questions.
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