The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular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More tough FDA draft guidance on stem cells…still no action Read More »
By Jeanne Loring Last Tuesday I visited the FDA headquarters in Maryland, for a meeting called Public Meeting on Patient-Focused Drug Development for Huntington’s and Parkinson’s Diseases. The FDA holds about 6 meetings on different diseases each year, inviting patients and advocates to speak while a panel of FDA directors listens. The FDA representatives at
Guest Post from Jeanne Loring: Patients talk stem cells. The FDA listens. 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 »
The US Congress recently held its first hearing on human germline genetic modification. The meeting included CRISPR-Cas9 pioneer Jennifer Doudna (see video here) on the panel. See image of Cas9 structure from Wikipedia. CRISPR-Cas9 is a powerful, strikingly efficient tool for genetic engineering of cells and whole organisms. Now Republican congressional leaders have included a
Congress: FDA should consult religious experts on embryo CRISPR Read More »
I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem
Interview with Bioheart CSO, Kristin Comella including on FDA 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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation Read More »
23andMe CEO, Anne Wojcicki, just emailed 23andMe customers (me included) with the big news that the FDA has approved the company to offer Bloom syndrome carrier status reporting. As Wojcicki points out, this is the first time ever that the FDA has granted authorization of a direct-to-consumer genetic test. This is a huge deal. Why
Landmark decision: FDA Approves 23andMe Genetic Test Read More »
You can comment here on this draft guidance.
FDA comment on draft guidance on minimal manipulation Read More »
You can comment on this FDA draft guidance here.
Adipose FDA guidance comments Read More »
