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Imprese · 03/03/20211 min di lettura
PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) 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 those NDAs.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →