Only One Week Away - SBIA | Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act Webinar

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance (SBIA) WEBINAR Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act September 8, 2022 | 9:30 a.m. - 3:30 p.m. ET This webinar is free.   Register Agenda ABOUT THIS WEBINAR In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations). FDA will also provide a discussion of registration and listing requirements, and how they pertain to the drug amount reporting program. The event will also include industry presenters, who will provide feedback regarding the drug amount reporting program. Conference participants will also have an opportunity to ask questions during question-and-answer sessions.     FDA RESOURCES Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act Guidance Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Proposed Order: Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act NextGen Portal https://www.fda.gov/drugs/drug-shortages/coronavirus-aid-relief-and-economic-security-act-cares-act-drug-shortage-miti drugamountreporting@fda.hhs.gov AUDIENCE Registrants (including contract manufacturer registrants) of listed drugs, including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs. The types of listed drugs also include medical gases, homeopathic products, over-the-counter drugs, and animal drugs. TOPICS COVERED Scope and purpose of drug amount reporting Connection between drug registration and listing requirements and section 510(j)(3) reports (including with respect to contract manufacturer reporting) Who in the supply chain is required to submit section 510(j)(3) reports Recommendations for how to report drug amount data, including for: non-US manufactured drugs private label distributed drugs multi-level packaged drugs applicant submitting report on behalf of a registrant Scenarios presented by industry regarding the drug amount reporting program 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 a maximum of 12 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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