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Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020 3 года назад


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Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020

FDA provides a regulatory foundation related to postmarketing drug safety reporting requirements and highlights the importance of submitting accurate, reliable, and timely safety data to FDA. Presenter: Kelley M. Simms CDR, USPHS Regulatory Policy Analyst Office of Surveillance and Epidemiology (OSE) | CDER _______________________________ 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 and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367

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