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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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Wouldn’t you like to be a RAT too? Stem cell clinics apply for new FDA accelerated approval path

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RAT-RMAT-designation

Are stem cell clinics going to somehow get the FDA to approve their stem cell interventions? To get recognized as legit? It seems they are trying now more than ever. Remember the REGROW Act that would have greatly reduced regulations on investigational stem cells and then how the 21st Century Cures Act passed with some

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FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

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The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA

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How Scott Gottlieb may transform the FDA’s approach to stem cells

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Dr.-Scott-Gottlieb

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such

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Good stem cell news on trials, FDA, cool new papers & more

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Pericyte-paper

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile

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FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act

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The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of

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Open letter to FDA: take action now on stem cell clinics before Trump

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FDA

Dear FDA, The stem cell clinic clock is ticking on you. Before the Trump administration rolls in to possibly tie your hands on many important areas of oversight including stem cell clinics, you should take bold action now. Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for

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Trump Has FDA in Crosshairs: Impact on Stem Cell Oversight?

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FDA-Trump-Healthcare

Will Trump trump the FDA? Our President-elect recently released his health care policy agenda and it looks like the FDA is a target in terms of reducing oversight. Over at the Washington Post, Carolyn Johnson has a nice article on this development. One point in the agenda in particular has caught people’s attention as potentially the key

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Internal FDA Fighting on Sarepta Bad Omen for Stem Cell Oversight?

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Exondys-51-Sarepta-

The FDA caused major controversy by approving the drug Exondys 51 from Sarepta Therapeutics for treating Duchenne muscular dystrophy over the recommendations of a scientific panel it convened that had voted 7-3 against approval. Is this contentious Sarepta approval serve as a sign of how the FDA will deal with stem cells moving forward? Will the FDA approval, which

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