SBIA | In Two Weeks - OTC Monograph Reform Webinar: Deemed Final Orders

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS OTC Monograph Reform: Deemed Final Orders December 15, 2021 1:00 PM - 2:00 PM ET Register ABOUT THIS WEBINAR This webinar will discuss: An overview of Over-the-Counter (OTC) Monograph Reform and will highlight Deemed Final Orders (DFOs). Certain final administrative orders (final orders), including for OTC drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The process for making these final orders available. The new web portal, OTC Monographs@FDA, which: Provides a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs. Facilitates the submission of comments and data from the public for proposed and interim final administrative orders, except if otherwise specified. TOPICS Overview of OTC Monograph Reform OTC Drug Review before and after the CARES Act Status of existing OTC monograph drugs after CARES Act Types of deemed final orders OTC Monographs@FDA Withdrawal of certain regulations from the Code of Federal Regulations (CFR) FDA SPEAKER Theresa Michele, MD Director Office of Nonprescription Drugs (ONPD) | CDER | FDA   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 CONTINUING EDUCATION 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 credits (appropriate to real-time attendance) 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 1 non-GCP or non-GLP unit 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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