Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Adminis... von THORNTON, Katherine, KIM, Geoffrey, GARNETT, Christine, QI LIU, BOOTH, Brian, GEHRKE, Brenda, DORSAM, Robert, VERBOIS, Leigh, GHOSH, Debasis, WILSON, Wendy, DUAN, John, SARKER, Haripada, MAHER, V. Ellen, POPE MIKSINSKI, Sarah, SKARUPA, Lisa, IBRAHIM, Amna, JUSTICE, Robert, MURGO, Anthony, PAZDUR, Richard, CHATTOPADHYAY, Somesh, SHENGHUI TANG, YOUNG JIN MOON, PENGFEI SONG, MARATHE, Anshu, BALAKRISHNAN, Suchitra, HAO ZHU

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FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Aut... von Brave, Michael, Farrell, Ann, Ching Lin, Sue, Ocheltree, Terrance, Pope Miksinski, Sarah, Lee, Shwu-Luan, Saber, Haleh, Fourie, Jeanne, Tornoe, Christoffer, Booth, Brian, Yuan, Weishi, He, Kun, Justice, Robert, Pazdur, Richard

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FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer von AMIRI-KORDESTANI, Laleh, BLUMENTHAL, Gideon M, RUSSELL, Anne M, MIKSINSKI, Sarah Pope, XIAO HONG CHEN, McGUINN, W. David, PALMBY, Todd, SCHRIEBER, Sarah J, QI LIU, JIAN WANG, PENGFEI SONG, MEHROTRA, Nitin, QIANG CASEY XU, SKARUPA, Lisa, CLOUSE, Kathleen, AL-HAKIM, Ali, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, CORTAZAR, Patricia, LIJUN ZHANG, TANG, Shenghui W, LINAN HA, WEINBERG, Wendy C, BO CHI, CANDAU-CHACON, Reyes, HUGHES, Patricia

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FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation von Kim, Geoffrey, McKee, Amy E, Ning, Yang-Min, Hazarika, Maitreyee, Theoret, Marc, Johnson, John R, Xu, Qiang Casey, Tang, Shenghui, Sridhara, Rajeshwari, Jiang, Xiaoping, He, Kun, Roscoe, Donna, McGuinn, W David, Helms, Whitney S, Russell, Anne Marie, Miksinski, Sarah Pope, Zirkelbach, Jeanne Fourie, Earp, Justin, Liu, Qi, Ibrahim, Amna, Justice, Robert, Pazdur, Richard

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Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications von Suarez-Sharp, Sandra, Delvadia, Poonam R., Dorantes, Angelica, Duan, John, Externbrink, Anna, Gao, Zongming, Ghosh, Tapash, Miksinski, Sarah Pope, Seo, Paul

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Dissolution Testing in Drug Product Development: Workshop Summary Report von Abend, Andreas, Curran, David, Kuiper, Jesse, Lu, Xujin, Li, Hanlin, Hermans, Andre, Kotwal, Pramod, Diaz, Dorys A., Cohen, Michael J., Zhang, Limin, Stippler, Erika, Drazer, German, Lin, Yiqing, Raines, Kimberly, Yu, Lawrence, Coutant, Carrie A., Grady, Haiyan, Krämer, Johannes, Pope-Miksinski, Sarah, Suarez-Sharp, Sandra

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Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development von Li, Min, Sander, Sanna, Duan, John, Rosencrance, Susan, Miksinski, Sarah Pope, Yu, Lawrence, Seo, Paul, Rege, Bhagwant

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Examining Manufacturing Readiness for Breakthrough Drug Development von Dye, Earl, Sturgess, Annie, Maheshwari, Gargi, May, Kimberly, Ruegger, Colleen, Ramesh, Usha, Tan, Heow, Cockerill, Keith, Groskoph, John, Lacana, Emanuela, Lee, Sau, Miksinski, Sarah Pope

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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference von Yu, Lawrence X., Baker, Jeffrey, Berlam, Susan C., Boam, Ashley, Brandreth, E. J., Buhse, Lucinda, Cosgrove, Thomas, Doleski, David, Ensor, Lynne, Famulare, Joseph, Ganapathy, Mohan, Grampp, Gustavo, Hussong, David, Iser, Robert, Johnston, Gordon, Kesisoglou, Filippos, Khan, Mansoor, Kozlowski, Steven, Lacana, Emanuela, Lee, Sau L., Miller, Stephen, Miksinski, Sarah Pope, Moore, Christine M. V., Mullin, Theresa, Raju, G. K., Raw, Andre, Rosencrance, Susan, Rosolowsky, Mark, Stinavage, Paul, Thomas, Hayden, Wesdyk, Russell, Windisch, Joerg, Vaithiyalingam, Sivakumar

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