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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 389 video lessons organized into 42 courses.  We are adding more each week.  Learn more about the website…

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FDA Proposes Waiving GDUFA Facility Fees for Domestic Manufacturers

Article Summary: The U.S. Food and Drug Administration (FDA) has proposed several changes to the Gen…

This Week at FDA

This Week at FDA: CDRH Annual Report, Partial Shutdown Update, and More

Article Summary: The FDA’s Center for Devices and Radiological Health (CDRH) released its 2025…

Makary’s Priorities: Faster Reviews, Domestic Manufacturing, and AI

Makary’s Priorities: Faster Reviews, Domestic Manufacturing, and AI

Article Summary: FDA Commissioner Marty Makary wants the same sense of urgency applied to the agency…

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