Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
We’ve heard of payphones, pay toilets, and other services for which people have to pay for access, but what about pay clinical trials? In a pay clinical trial, patients have to pay anywhere from $10K to over $100K to get in the door. I asked readers of this blog about how they feel about patients having to pay those running clinical trials just to get into the trials of experimental therapies. In that poll, 70% of the more than 120 responses felt negatively about …Read More
The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for …Read More