RMAT

Cell and gene therapy products: what is an ATMP?

atmp therapy

If you were to see the phrase ‘Advanced Therapy Medicinal Product’ (ATMP) you might guess, ‘an advanced treatment that is a medicine?’ but you will not get much more from this without doing a lot more homework. What is an ‘Advanced Therapy Medicinal Product’ (ATMP)? Whoever decided that cell and gene therapy products should be described …

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20/20 vision? The Niche’s 20 stem cell & regenerative medicine predictions for 2020

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Every year in December and early January I do a post predicting some key events for the stem cell and regenerative medicine field for the upcoming year and today’s post contains my predictions for 2020. You can see my past 2019 predictions along with my grades for them here. I gave myself a B+ for …

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Take-homes from new FDA NEJM stem cell piece including surprises

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FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some …

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US Stem Cell bid for FDA RMAT rejected?

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Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The …

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Big change for stem cell field with FDA quickly issuing RMATs

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The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation. I don’t think anyone was sure …

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