Mary C. Holloway; Order Revoking a Proposed Order of Debarment

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The Food and Drug Administration (FDA) is revoking a proposed order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to debar Mary C. Holloway (Holloway) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. Holloway, through counsel, filed a request for a hearing, as well as information and analysis in support of that request, in response to the proposed debarment order. FDA has determined that pursuing debarment of Holloway is no longer appropriate.