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Re: rosemountbomber post# 435662

Thursday, 05/08/2025 1:12:43 PM

Thursday, May 08, 2025 1:12:43 PM

Post# of 437212
Appears no one has heard of, or dealt with, FDA's OCI(Office of Criminal Investigation). See Compliance Policy Guide, CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, etc. Some 11 generic companies were found to have falsified data in pre-market applications to FDA in 1988. OCI came into existence ~ 1990. Washington D.C. field office was established in 1993. 

FDA can withdraw approval of applications filed for approval of drugs when evidence of fraud is found to exist. The above  field Office( covers southern N.J. also) will be reading/hearing about Hikma and Dr. Reddy activities in attorneys' creation of falsified evidence of prior art that was incorporated in the Nevada District Court opinion of J. Du 4-5 years ago. Remember the facts and law set forth in the Amarin Shareholders Petition for Writ of Certiorari, denied for lack of standing. No court has yet to express any rational opinion discussing those facts and law. 

Coincidentally, the Federal Circuit Bar Association is having a virtual discussion of the interaction between Food and Drug Law and Intellectual Property Law this afternoon at 2 pm.
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