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Geschäft · 18.11.20191 Min. Lesezeit
Pan American Laboratories, LLC, et al.; Proposal To Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of four new drug applications (NDAs) from multiple NDA holders and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for these NDAs.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →