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The Food and Drug Administration (FDA) has issued a final order denying Bernardo Garmendia's request for a hearing and has permanently banned him from providing services related to drug products. This decision stems from Garmendia's conviction for conspiracy to commit wire fraud while working at AMB Research Center, where he was involved in falsifying clinical trial documents. As of March 14, 2025, using Garmendia’s services in any drug application process incurs civil penalties for involved parties. This ruling highlights the FDA's commitment to safeguarding drug development processes.

The Food and Drug Administration (FDA) issued a permanent debarment order against Alec Burlakoff under the Federal Food, Drug, and Cosmetic Act. Burlakoff was convicted of a felony involving illegal activities with a drug called SUBSYS while working at Insys Therapeutics. His actions included bribing doctors to prescribe the drug, often to patients who did not have cancer. As a result, Burlakoff is banned from providing services related to drug product applications, and there are penalties for any approved drug product applications that employ him during this period.