A "viewpoint"paper that appeared in JAMA two weeks ago, co-authored by the Commissioner of the FDA. It outlines efforts at the Agency to crack down on unapproved stem cell treatments, and gives the steps needed to obtain an IND to pursue legitimate development of regenerative medicines. A nice snapshot of where the FDA currently stands. Apologies if it's already been posted on another thread:
https://jamanetwork.com/journals/jama/fullarticle/2767586
Analysis of the EAP, page-893
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