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Last Updated: October 1, 2026
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Summary
How does a new drug actually get approved by regulatory agencies the US FDA and EMA? In this explainer, we break down ... Before a new drug can be tested in humans, it must undergo extensive nonclinical studies to evaluate its safety and biological ... Katie Lewis(Global Regulatory Operations Manager, Amgen) Benefit from 90% discount coupon on all College's online courses Before 1989, getting a life-saving drug approved globally meant shipping truckloads of paper binders and re-formatting millions of ... 00:00 - Welcome & Introductions 2:22 - What is FDA Annual Reports Explained | Complete Guide Three deep-dive episodes on the regulatory endgame — submitting 412000 pages to FDA in Rajesh Krishna, Senior Director with IDD Certara, reflects on how decision analysis can be used to support drug development. Last Minute Lecture is a student-run project and is currently funded entirely by students who believe educational resources should ...