June 6, 2020

The Niche

Knoepfler lab stem cell blog

Peter Marks FDA

2 min read

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a …Read More

3 min read

I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of the AP, Terry Devitt of the University of Wisconsin, and Dr. Peter Marks, Head of CBER at the FDA (pictured). Marilynn and Terry ran the session. The session was …Read More