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Entreprise · 02/12/19981 min de lecture
Vale Chemical Co., Inc., et al.; Proposal to Withdraw Approval of 13 New Drug Applications and 1 Abbreviated New Drug Application; Opportunity for a Hearing
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Résumé
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDA's) and 1 abbreviated new drug application (ANDA). The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →