October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

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Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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[WEBINAR] Live Q+A for ‘Assess Your CER for MDR Readiness, Part 1’ with Laurie

We had a large turnout at our webinar on April 29, 2020, “How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review.” We ended with many unanswered questions. To answer these and more questions, President Laurie Mitchell is coming back to host a Question & Answer session LIVE.

Jun 4, 2020 11:00 AM in Pacific Time (US and Canada)

Click here to register for this free webinar