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Negocios · 28/6/20071 min de lectura
Menley & James Laboratories, Inc. et al.; Proposal to Withdraw Approval of Six New Drug Applications; Opportunity for a Hearing
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of six 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 de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →