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Newsletter - January 30, 2020

FDA’s Interpretation of HCT/Ps is Subject to Legal Review - Federal Judge

A Federal judge in California ruled that FDA’s interpretation of its own Guidance Documents regarding autologous cell therapy is faulty and hence subject to legal challenge. Specifically, the judge ripped through FDA interpretation of the “same surgical process” exemption for the regulation of Human Cellular and Tissue-based Products (HCT/P). Read More 
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Shkreli Keep Giving Valuable Lessons in the Dirty Secrets of the Drug Industry​
It has been a few years since the infamous Martin Shkreli was in the news. And we have another opportunity to thank him for exposing (unintentionally, of course!) some of the worst secret practices of the drug industry. This time Mr. Shkreli shows how companies can use non-disclosure agreements and exclusivity contracts to... Read More

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