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Entreprise · 17/12/20121 min de lecture
Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of New Animal Drug Applications; Opportunity for a Hearing
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Résumé
The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →