Negócios · 10/07/19971 min de leitura
Global Pharmaceutical Corp. et al.; Proposal to Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing
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Resumo
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.