Tag: NDA

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

CDER SBIA Webinar: Forms FDA 3542a and 3542

A free On-Demand Webinar is available for viewing that addresses updates made to Forms FDA 3542a and 3542. An overview of the forms is provided as well as answers to frequently asked questions. Link: www.fda.gov/drugs/development-approval-process-drugs/demand-webinar-what-new-forms-fda-3542a-and-3542?utm_campaign=CDERSBIA%20Webinar%3A%20Form%203542&utm_medium=email&utm_source=Eloqua This webinar describes the recent updates made to Forms FDA 3542a and 3542, which NDA applicants holders use to submit […]

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