2023-02161: Sami Anwar; Denial of Hearing; Final Debarment Order
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The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Sami Anwar (Anwar) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Anwar from providing services in any capacity to a person having an approved or pending drug product application. FDA bases this order on a finding that Anwar was convicted of felonies under Federal law for conduct relating to the development or approval of any drug product or otherwise relating to the regulation of a drug product under the FD&C Act. Anwar failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.
The agency’s own summary, as published.
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