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The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular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More tough FDA draft guidance on stem cells…still no action Read More »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 »
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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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
ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation Read More »
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
FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet? Read More »
With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem
FDA Draft Guidance Views Fat Stem Cells As Drugs Read More »
It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank
FDA on Key Stem Cell Regulatory Issues & Its Own Research Read More »
What the heck happened to the FDA when it comes to regulating stem cell clinics? Has it given up? Or does it just seem that way because it moves in slow motion? The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years.
Has the FDA given up on regulating stem cell clinics? Read More »
We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on
What is the FDA’s appropriate role in regulating medical innovations such as stem cells? Read More »