Now that in the past few months the FDA has issued stern statements (one this summer and more recently), both final and draft guidances, and at least one warning letter, what comes next? What will the clinics do if anything moving forward? What if anything will the FDA do in terms of actual concrete actions? Please take our polls below. Regarding potential FDA actions, I’ve just used the word “letters” in the poll since the FDA can issue impactful letters that are either untitled …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 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
The poll I put up asking people their #1 top priority for FDA reform drew relatively big numbers of respondents. Speeding up clinical trials was clearly way out in front at #1. Expanding compassionate use was #2. These were followed by changing policy to no longer define lab-grown stem cells as drugs and FDA being more proactive against non-compliant clinics.