FDA stromal vascular fraction

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

FDAADF-300x252

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 »

FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

Gionis-Warning-Letter

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 »

More tough FDA draft guidance on stem cells…still no action

FDAADF-300x252

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular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More tough FDA draft guidance on stem cells…still no action Read More »