FDA Stem Cell Meetings Close at Hand: Stakeholders on Both Sides are Worried, but One Side Should be Really Worried.
Next Monday and Tuesday, September 12 and 13th is a widely acknowledged big day in the stem cell world; it’s the two day public hearing on the FDA’s four draft guidance documents. (Here is a link to the FDA’s announcement. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. The entire event will be live broadcast via a link on this FDA page. The draft guidances are a big deal because, as I’ve said before, http://rickjaffeesq.com/2016/04/21/stemcells/, they will make illegal almost all autologous cell transplants outside of FDA…