December 1, 2020

The Niche

Knoepfler lab stem cell blog

FDA stem cell clinics

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

1 min read

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 reflect a great deal of dissatisfaction with the job that the FDA is doing on stem cell clinics. Only 9% of respondents felt that the FDA is currently do …Read More