The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Maria Giron, M.D. 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 Dr. Giron 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. Dr. Giron 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), Dr. Giron has not responded. Dr. Giron's failure to respond and request a hearing constitutes a waiver of Dr. Giron's right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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