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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 396 video lessons organized into 43 courses.  We are adding more each week.  Learn more about the website…

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This Week at FDA

This Week at FDA: Speedy Drug Review Bonuses, Makary Defends Prasad, and More

Article Summary: This week’s FDA updates focus on regulatory reforms, product approvals, and s…

FDA Sign at White Oak

FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development

Today, FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommenda…

This Week at FDA

This Week at FDA: Single Pivotal Trials, FDA Reverses Course to Review Moderna Flu Vaccine, and Makary’s OTC Turn

Article Summary: This Week at FDA highlights several significant regulatory developments. The most n…

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