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Negócios · 28/03/20001 min de leitura
John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated 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 158 abbreviated new drug applications (ANDA's). 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 →