The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Jonathan R. Shaver 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. Shaver 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. Shaver was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 16, 2024 (30 days after receipt of the notice), Mr. Shaver has not responded. Mr. Shaver's failure to respond and request a hearing constitutes a waiver of Mr. Shaver's right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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