Jessica Palacio; Denial of Hearing; Final Debarment Order

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Andrew S. Feldman, on behalf of Jessica Palacio (Palacio), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Palacio from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Palacio was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Palacio of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Palacio submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.

Abstract as published in the Federal Register.

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