Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through the US v. Regenerative Sciences Inc. (RSI) case providing helpful and insightful perspectives on the history of the case and their prediction as to the likely outcome on appeal. …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.
The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector. It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field. If you could change just one thing about the FDA in terms of its oversight of the stem cell field, what would it be? I realize some people may want to click more than one, but try to pick just your #1 in the …Read More