Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Session 2 скачать в хорошем качестве

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Session 2

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 01:30 – CARES Drug Amount Report Examples 41:08 – Question & Answer Panel Speakers: 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 Panelists: 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