Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act – Session 3 and Closing Remarks скачать в хорошем качестве

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act – Session 3 and Closing Remarks

During this webinar, FDA provided 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 also provided a discussion of registration and listing requirements, and how they pertain to the drug amount reporting program. Timestamps 01:03 – CARES Act OTC Drug Volume Reporting – Perrigo 19:30 – Johnson & Johnson Consumer Inc. - CARES Act Drug Amount Reporting – OTC Products 36:46 – Reporting Drug Amounts Under Section 510 of the FD&C Act as an Authorized Agent and cGMP Consultant 55:28 – Drug Volume Reporting: Industry Perspective 1:11:10 – Question & Answer Panel 1:45:14 – Closing Remarks Speakers: Kim Armstrong Associate Director Perrigo OTC Regulatory Affairs Operations Gracy Tirado Associate Director RA Compliance Johnson & Johnson Consumer Inc. Ken Coleman ("KC") Stevenson II VP of Regulatory Ceutical Laboratories, Inc. Ben Harpster QA Compliance Manager GlaxoSmithKline Jennifer Forde Regulatory Counsel Office of Regulatory Policy (ORP) Center for Drug Evaluation and Research (CDER) | FDA Panelists: Jennifer Forde Regulatory Counsel Office of Regulatory Policy (ORP) Center for Drug Evaluation and Research (CDER) | FDA Jennifer Highland Operations Research Analyst Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) | FDA Obinna Ugwu-Oju Division Director Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) | FDA Edward Hallissey Project Management Officer Office of Strategic Programs (OSP) Center for Drug Evaluation and Research (CDER) | FDA Daniil Graborov Computer Scientist Office of Business Informatics (OBI) Center for Drug Evaluation and Research (CDER) | FDA Learn more at: Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - 09/08/2022 | FDA ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367