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Entreprise · 10/07/19971 min de lecture
Global Pharmaceutical Corp. et al.; Proposal to Withdraw Approval of Four New Drug Applications; 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 four new drug applications (NDA's). 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 →