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 reach out to the FDA to clarify the process. PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind …Read More
same-day surgical procedure stem cells
The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular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 thought in the for-profit stem cell clinic field. “Industry” apparently hasn’t been happy about this. For instance, December 2014 FDA draft guidance very clearly indicated that fat-related stem cell products …Read More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 2020, the FDA has now clearly defined fat stem cells as drug products and filed suit against two firms marketing unapproved fat stem cells.) These new FDA guidances indicate …Read More