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

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

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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The year in review and some predictions about next year/ Part One: Stem Cells

The year in review and some predictions about next year/ Part One: Stem Cells

It’s time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells. We started 2017 awaiting the FDA’s final guidance documents on HCT/P’s (“stem cells”). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/P’s were in violation of the FDA trifecta…

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