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 […]
The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various […]
Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cells? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove […]
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