SBIA | OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings

Registration Open!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings March 29, 2022 2:00 PM - 3:00 PM ET Register ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the recently published draft guidance for industry titled Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs.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Explain OMUFA Timelines   TOPICS COVERED Overview of OTC Monograph Reform Overview of the formal monograph meetings draft guidance Meeting types and formats Content and format of meeting requests Meeting request responses, meeting scheduling, and timelines Meeting packages, preliminary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 SPEAKER 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 FDA RESOURCES OTC Monograph Reform in the CARES Act OTC Monographs@FDA Over-the-Counter OTC/Nonprescription Drugs Guidances 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: pre-approved by RAPS as eligible for credits (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. 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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