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Zdrowie i gospodarka · 19.03.2020

Brenda Elise Edwards: Final Debarment Order

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Brenda Elise Edwards 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 Mrs. Edwards was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mrs. Edwards was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of January 2, 2020 (30 days after receipt of the notice), Mrs. Edwards had not responded. Mrs. Edwards's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this action.

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