The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell […]
Stem cell clinic group, Cell Surgical Network, fires PR back at FDA Read More »
The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already
Six questions as FDA takes new shot at stem cell clinics Read More »
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
Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine Read More »
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
Guide to September 12-13 FDA Stem Cell Meeting Read More »
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
Perspectives: Nature editorial on stem cell oversight & clinics gets it right Read More »
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
Huge clinical trial fees allowed by FDA at times, details often secret Read More »
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:
FDA stem cell meeting now a 2-day public event in September Read More »
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
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
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
More tough FDA draft guidance on stem cells…still no action Read More »
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
FDA far too weak on stem cell clinics says poll Read More »