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Negócios · 28/01/20051 min de leitura
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing
Tradução automática local · Idioma original da fonte
Resumo
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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →