FDA Premarket Regulation of Tissue-Engineered Replacement… : DASH Story 2016-01-14
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I am Regulatory Science professional with about 2 decades of experience in the drug and device industry. I have recently transitioned from industry to academia, where I give seminars on Regulatory Strategy and FDA Engagement for Drugs and Devices at universities and also serve as an advisor to startup drug and device companies founded by university students. While working on a new approach to tissue engineering by a startup, I made a preliminary assessment of the regulatory strategy and then a did a quick research on any related publications. I was delighted to read your article as it supported my initial assessment! Thanks for the great work and to the university for open access.
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