Бизнес · 28.01.20051 мин чтения
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
Локальный автоматический перевод · Язык оригинального источника
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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 (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.