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![]() Date: 2016-07-11 17:00:04Clinical research Food and Drug Administration Pharmaceutical industry Drug safety Savient pharmaceuticals Pharmaceuticals policy Pegloticase Biologic license application PEGylation Validation Pharmacovigilance Clinical trial | Add to Reading List |
![]() | Microsoft Word - Savient Resubmits Biologics License Application for KRYSTEXXAdocDocID: 1qqBA - View Document |
![]() | Microsoft Word - Savient Update on KRYSTEXXA BLA FilingdocDocID: 1ot1g - View Document |
![]() | PDF DocumentDocID: 16eHM - View Document |
![]() | BLA Complete Response LetterDocID: 14Ctf - View Document |
![]() | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]MEMORANDUM Date:DocID: XoPt - View Document |