- May 29, 2020
This webinar provides a general overview of monograph reform, how it impacts FDA’s regulation of monograph products, and how it affects industry and the public. The webinar will address most commonly asked questions.
- The current system of regulating over-the counter drugs and why there was a need for reform of the monograph system
- The key elements of the Monograph Reform legislation including Monograph Order Requests and Administrative Orders and the impact on regulation of drugs that meet monograph conditions
- How FDA will transition all the monographs into Administrative Orders whether those monographs are final monographs or tentative final monographs
- How sponsors who have over-the-counter drugs might consider preparing for Monograph Reform
- Regulatory affairs professionals working on new drugs or dosage forms for the consumer, known as over-the-counter (OTC) drugs or nonprescription drugs
- Clinical research coordinators
- Consultants focused on development of OTC drugs or nonprescription drugs for the consumer
- Foreign regulators following the development of OTC drugs or nonprescription drugs for the consumer
- Importers of OTC drugs or nonprescription drugs for the consumer
- General public with an interest in OTC or nonprescription drugs
Theresa M. Michele, MD
Director, Office of Nonprescription Drugs | CDER | FDA
Karen M. Mahoney, MD
Deputy Director, Office of Nonprescription Drugs | CDER | FDA
- Status of OTC Rulemakings
- FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
- SOCRA 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 RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- 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 medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
- Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.
Please contact CDERSBIA@fda.hhs.gov for all technical questions.
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|Monograph Reform is Here!||pdf (528.80 KB)|