good manufacturing practices | Richard Jaffe, Esq.

Is cord blood/umbilical cord stem cell treatment legal?

February 8, 2019 Richard Jaffe Comments 0 Comment

Virtually all the attention I’ve given to stem cells in my prior posts has been on autologous stem cell transplants. But the private stem cell clinic industry actually started with cord blood back in the early part of this century. I have written about the start of this field and the FDA’s first two cord blood clinic criminal investigations in Galileo’s Lawyer. The short of it is that even back then, the FDA didn’t think a private clinic’s use of…

FDA sends a Happy New Year greeting to another stem cell operation!

January 5, 2018 Richard Jaffe Comments 0 Comment

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities. Here is the warning letter: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm Same ol, same ol, but with a twist The letter is largely the FDA’s standard form warning…

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