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

January 25, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

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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Perspectives on Cures Act stem cell provisions possible benefits & risks

November 30, 2016 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

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The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field. What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the …

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Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions

November 29, 2016 February 1, 2021 / By Professor Paul Knoepfler, Ph.D.

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much …

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Japan stem cell oversight system too lax?

May 31, 2018 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 10 Comments

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The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted …

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Mesoblast gets FDA RMAT; List of 10 total designations so far

December 26, 2017 August 23, 2022 / By Professor Paul Knoepfler, Ph.D. / 13 Comments

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …

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Stem cell good news for the holidays: biotechs, FDA, organoids

December 7, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D.

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I can see many reasons to be jolly on the regenerative medicine front as we get deeper into the holiday season as there is quite a lot of stem cell good news even if there is also some not so good news. In today’s post the focus is on the good news of late. Semma …

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Fat stem cells are drugs: new FDA final guidances

November 16, 2017 September 3, 2022 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

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Cynata stem cell trial update: CEO Ross Macdonald interview

July 3, 2017 February 22, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

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Stem cell clinical trials have a certain gravitational pull for me as I’m always fascinated by them and since the new Cynata trial is moving forward, I recently did an interview their CEO, Dr. Ross A. Macdonald to find out more. PK: Cynata’s recently initiated clinical trial aims to treat GVHD as have other stem …

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US Stem Cell bid for FDA RMAT rejected?

June 22, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

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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FDA warp speed RMAT approval nukes stem cell clinic excuses

June 15, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. …

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