İş dünyası · 22.07.20221 dk okuma
Panray Corp. Sub Ormont Drug and Chemical Co., Inc., et al.; Withdrawal of Approval of Three New Drug Applications
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Özet
The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for the identified NDAs.