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Imprese · 02/12/19981 min di lettura
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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Riepilogo
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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →