Analysis of FDA warning letters related to cell/ tissue products
US FDA regulates therapeutic human cell/ tissue products (HCT/P) and its whole manufacturing process. Academic and industry cell therapy manufacturing facilities can get inspected by FDA at any time...
View ArticleLetters from regulators: MAPC-containing product is a drug
I’m starting new series – Letters from regulators. In this series I’ll analyze issues with regulation of cellular products, resulted in letters or other actions from regulatory agencies. I hope this...
View ArticleLetters from regulators: Misbranding and adulteration of PRP device
This is a second post of the series Letters from Regulators. In this series I’ll analyze issues with regulation of cellular products, resulted in letters or other actions from regulatory agencies....
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