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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 383 video lessons organized into 41 courses.  We are adding more each week.  Learn more about the website…

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This Week at FDA

This Week at FDA: Drug Voucher Program Hits a Snag, GOP Targets Abortion Drug, and More

Article Summary: This week’s FDA update covers a range of regulatory issues and developments. …

Guiding Principles of Good AI Practice in Drug Development

FDA and EMA Release Guiding Principles of Good AI Practice in Drug Development

Today, after several months of collaboration, the FDA and the European Medicines Agency (EMA) are re…

This Week at FDA

This Week at FDA: FDA Eases Digital Health Oversight, MDUFA Negotiation Update, and More

Article Summary: This week, the FDA has made several updates and announced upcoming events related t…

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