Day: January 30, 2020

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 artificially keep … Read more

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). The case in point was a … Read more