FDA Archives - Page 7 of 10

Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine

July 11, 2017 / Professor Paul Knoepfler, Ph.D. / 3 Comments

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in […]

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Guide to September 12-13 FDA Stem Cell Meeting

September 11, 2016 / Professor Paul Knoepfler, Ph.D. / 5 Comments

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have

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Perspectives: Nature editorial on stem cell oversight & clinics gets it right

July 7, 2016 / Professor Paul Knoepfler, Ph.D.

The journal Nature published an excellent editorial earlier this week on stem cell oversight and stem cell clinics. The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and

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Huge clinical trial fees allowed by FDA at times, details often secret

May 22, 2016 / Professor Paul Knoepfler, Ph.D. / 9 Comments

Why can there be huge clinical trial fees for participants? I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But

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FDA stem cell meeting now a 2-day public event in September

May 7, 2016 / Professor Paul Knoepfler, Ph.D. / 3 Comments

The FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September. This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments. FDA stem cell meeting From the FDA announcement on the meeting:

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FDA warning points to tougher regulation of fat stem cells & clinics

January 24, 2016 / Professor Paul Knoepfler, Ph.D. / 10 Comments

Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment

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More tough FDA draft guidance on stem cells…still no action

November 5, 2015 / Professor Paul Knoepfler, Ph.D. / 33 Comments

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally

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FDA far too weak on stem cell clinics says poll

September 8, 2015 / Professor Paul Knoepfler, Ph.D. / 2 Comments

I recently ran a poll on my blog about how the FDA is doing on handling stem cell clinics. There is substantial debate in the stem cell arena about how the FDA handles stem cell clinics ranging from the view that the agency is far too strict to excessively lenient. The results of the poll

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ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

March 4, 2015 / Professor Paul Knoepfler, Ph.D.

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has

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FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet?

January 5, 2015 / Professor Paul Knoepfler, Ph.D. / 28 Comments

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of

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