FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
Gwynn Ison(United States Food and Drug Administration), Richard Pazdur(United States Food and Drug Administration), Anuradha Ramamoorthy(United States Food and Drug Administration), Hisani N. Horne(United States Food and Drug Administration), Okponanabofa Eradiri(University of Alberta), Amna Ibrahim(Beni-Suef University), Soma Ghosh(Center for Devices and Radiological Health), Reena Philip(Center for Devices and Radiological Health), Gideon M. Blumenthal(Merck & Co., Inc., Rahway, NJ, USA (United States)), Kaushalkumar Dave(United States Food and Drug Administration), Kumar G. Janoria(Center for Drug Evaluation and Research), Shenghui Tang(United States Food and Drug Administration), Sharon L. Kelly(United States Food and Drug Administration), William F. Pierce(United States Food and Drug Administration), Todd R. Palmby(University of North Carolina at Chapel Hill), Paul G. Kluetz(United States Food and Drug Administration), Laleh Amiri‐Kordestani(United States Food and Drug Administration), Wimolnut Manheng(United States Food and Drug Administration), Kirsten B. Goldberg(United States Food and Drug Administration), Pengfei Song(Nanyang Technological University), Jeannette Dinin(Center for Drug Evaluation and Research), Fang Li(Jiangsu Province Hospital), Jingyu Yu(Center for Drug Evaluation and Research), Anamitro Banerjee(United States Food and Drug Administration), Eunice Y. Lee(United States Food and Drug Administration), Rajeshwari Sridhara(Center for Drug Evaluation and Research), Vadryn Pierre(AstraZeneca (United States)), Lynn Howie(United States Food and Drug Administration), Rosane Charlab, Lijun Zhang(Dalian Medical University), Julia A. Beaver(Center for Drug Evaluation and Research)
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