The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis

In this Regenerative Medicine Special Report, learn more about the US direct-to-consumer marketplace for stem cell interventions.

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Jan 19, 2018
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Hundreds of businesses in the US currently advertise a wide range of non-US FDA-approved stem cell interventions. In this Regenerative Medicine Special Report, Paul S Knoepfler and Leigh G Turner present a novel systematic temporal analysis of US companies engaged in direct-to-consumer marketing of putative stem cell treatments. Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year.

From 2014 to 2016, approximately 90-100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed.

Knoepfler PS, Turner LG. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis. Regen. Med. doi: 10.2217/rme-2017-0115 (2018)(Epub ahead of print)

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Regenerative Medicine

Journal, Future Science Group

Regenerative Medicine is an award-winning peer-reviewed journal, in print and web formats. The journal provides a forum to address the important challenges and advances in stem cell research and regenerative medicine, delivering this essential information in concise, clear and attractive article formats. Among other indexing services Regenerative Medicine is listed by MEDLINE/Index Medicus, EMBASE/Excerpta Medica, Chemical Abstracts, Science Citation Index Expanded™ (SciSearch®), Emcare, Biological Abstracts, BIOSIS Previews, Biotechnology Citation Index®, Journal Citation Reports/Science Edition®, Scopus® with an Impact Factor of 2.786 (2014). Each issue contains expertly drafted Reviews, Original Research articles, Perspectives, Editorials, topical insight from international leaders in their field, and additional added-value content. The Senior Editor of the journal is Professor Chris Mason, University College London. You can find out more about Regenerative Medicine at our website (www.future-science-group.com/journalprofile/regenerative-medicine/), where you can find the aims and scope of the journal and details of our international editorial board.

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