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Welcome!  This website was created to preserve and organize FDA-produced learning materials in a structured, course-style format.  It currently holds 379 video lessons organized into 40 courses.  We are adding more each week.  Learn more about the website…

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This Week at FDA

This Week at FDA: New Guidance, Shutdown Pay Issues, and Another Inspection Overhaul

Article Summary: This week, the FDA has continued its work despite the ongoing government shutdown, …

FDA Sign at White Oak

FDA Publishes NDA Filing Checklist to Avoid Application Derailments

Article Summary: The US Food and Drug Administration (FDA) has made public the internal checklists u…

FDA White Oak

FDA’s Drug and Biologics Centers Report Steep Drop in Headcount in FY 2025

Article Summary: The US Food and Drug Administration’s (FDA) two key centers, the Center for D…

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