There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. Bipartisan Policy Center […]
Cons Outweigh Potential Pros to BPC Plan on Stem Cells & FDA Read More »
One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning
To stem cell clinics: do your homework & take FDA “current thinking” seriously Read More »
A couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills. You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which
Content Wiped on Websites of Stem Cell Clinics Warned by FDA Read More »
The FDA has delayed the planned big April public meeting on stem cells until later this year. Basically, the reason given is that more time is needed for stakeholders to comment. It will be interesting to see if the FDA expands the meeting beyond the 1-day format, which was going to allow each speaker only
Breaking: FDA postpones big stem cell public meeting Read More »
Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to
New FDA Interview on April stem cell meeting & draft guidances Read More »
For the first time I have ever seen in at least half a dozen years, a major newspaper in the form of The Boston Globe has published an editorial on FDA regulation of stem cells. The editorial, entitled “It should be safety-first on stem cell therapies”, argues that while we should take patient concerns into
Historic Boston Globe editorial on FDA, stem cells & patients argues safety first Read More »
The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of
FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces 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 has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN)
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
After a seemingly endless period of review, the FDA has approved the genetically modified (GM) AquaBounty salmon for sale and consumption. Update: You might find my interview with George Church on CRISPR and gene modification interesting. I don’t see any particular reason to think that this GM fish as a food would pose any significant
FDA approves 1st GM animal (fast-growing salmon) to eat Read More »