No, not an issue with the FDA. This is about someone without the proper medical/clinical trial training running sham studies to trick patients into believing they are participating in a legitimate clinical trials being properly reviewed and adhering to Good Clinical Practices (GCP) and in partnership with the regulatory authority for the United States (the FDA). Ask any regulatory specialist how to manage an FDA inspection and how to respond to 483s and FDA warning letters. That’s not even close to a proper response. It’s embarrassing and Shameful, showing not one ounce of respect for this important safety net to protect patients.
I work in this industry. I’m also a legitimate PhD and clinical expert in drug development. Perhaps you should consult with a regulatory expert if you don’t believe me. This is wrong on to many levels and Kristi is about to be smacked with a life changing lesson of her own making! 20 years from now she can write a book entitled The All New Orange Is The New Black - Kristi’s Story... I hope she gets substantial prison time!!!!!!
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