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Zdrowie i gospodarka · 24.07.2020

Paul J. Elmer: Final Debarment Order

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Paul J. Elmer 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 Mr. Elmer was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Elmer was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 11, 2020 (30 days after receipt of the notice), Mr. Elmer had not responded. Mr. Elmer's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

Source: Federal Register — Food and Drug AdministrationOpen original release →