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More articles from CCR Perspectives in Regulatory Science and Policy

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    Michael B. Atkins, Clara Curiel-Lewandrowski, David E. Fisher, Susan M. Swetter, Hensin Tsao, Julio A Aguirre-Ghiso, Maria S Soengas, Ashani T Weeraratna, Keith T. Flaherty, Meenhard Herlyn, Jeffrey A. Sosman, Hussein A. Tawbi, Anna C Pavlick, Pamela B Cassidy, Sunandana Chandra, Paul B. Chapman, Adil Daud, Zeynep Eroglu, Laura K Ferris, Bernard A. Fox, Jeffrey E Gerhsenwald, Geoffrey T Gibney, Douglas Grossman, Brent A. Hanks, Douglas Hanniford, Eva Hernando, Joanne M. Jeter, Douglas B. Johnson, Samir N. Khleif, John M. Kirkwood, Sancy A. Leachman, Darren Mays, Kelly C. Nelson, Vernon K. Sondak, Ryan J. Sullivan, Glenn Merlino
    Clinical Cancer Research Jan 2021, clincanres.4092.2020; DOI: 10.1158/1078-0432.CCR-20-4092
  • U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program
    R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur
    Clinical Cancer Research Jan 2021, 27 (1) 11-14; DOI: 10.1158/1078-0432.CCR-20-2220
  • Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies
    Jamie R. Brewer, Elaine Chang, Sundeep Agrawal, Harpreet Singh, Daniel L. Suzman, James Xu, Chana Weinstock, Laura L. Fernandes, Joyce Cheng, Lijun Zhang, Diqiong Xie, Kirsten B. Goldberg, Erik W. Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Marc R. Theoret, Richard Pazdur, Amna Ibrahim, Julia A. Beaver
    Clinical Cancer Research Dec 2020, 26 (24) 6406-6411; DOI: 10.1158/1078-0432.CCR-19-4229
  • Project Orbis: Global Collaborative Review Program
    R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Michael Shum, Laila Sofia Mouawad, Gustavo Mendes Lima Santos, Kelly Robinson, Melissa Hunt, Caroline Healy, Agnes Chan, Yee Hoo Looi, Clare Rodrigues, Ulrich-Peter Rohr, Chantal Walther, Richard Pazdur
    Clinical Cancer Research Dec 2020, 26 (24) 6412-6416; DOI: 10.1158/1078-0432.CCR-20-3292
  • FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
    Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine A Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue, William F Pierce, Stacy Shifflett Shord, Jennifer J Gao, Richard Pazdur
    Clinical Cancer Research Jan 2020, clincanres.3213.2020; DOI: 10.1158/1078-0432.CCR-20-3213
  • Advancing Drug Development in Gynecologic Malignancies
    Julia A. Beaver, Robert L. Coleman, Rebecca C. Arend, Deborah K. Armstrong, Sanjeeve Bala, Gordon B. Mills, Anil K. Sood, Thomas J. Herzog
    Clinical Cancer Research Aug 2019, 25 (16) 4874-4880; DOI: 10.1158/1078-0432.CCR-19-0619
  • Clinical Development of Novel Drug–Radiotherapy Combinations
    Saif S. Ahmad, Marka R. Crittenden, Phuoc T. Tran, Paul G. Kluetz, Gideon M. Blumenthal, Helen Bulbeck, Richard D. Baird, Kaye J. Williams, Tim Illidge, Stephen M. Hahn, Theodore S. Lawrence, Patricia A. Spears, Amanda J. Walker, Ricky A. Sharma
    Clinical Cancer Research Mar 2019, 25 (5) 1455-1461; DOI: 10.1158/1078-0432.CCR-18-2466
  • Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections
    Janice Kim, Harpreet Singh, Kassa Ayalew, Kristina Borror, Michelle Campbell, Laura Lee Johnson, Alyson Karesh, Ni A. Khin, Joanne R. Less, Jerry Menikoff, Lori Minasian, Sandra A. Mitchell, Elektra J. Papadopoulos, Richard L. Piekarz, Kevin A. Prohaska, Susan Thompson, Rajeshwari Sridhara, Richard Pazdur, Paul G. Kluetz
    Clinical Cancer Research Apr 2018, 24 (8) 1780-1784; DOI: 10.1158/1078-0432.CCR-17-2555
  • The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications
    Kenneth C. Anderson, Daniel Auclair, Gary J. Kelloff, Caroline C. Sigman, Hervé Avet-Loiseau, Ann T. Farrell, Nicole J. Gormley, Shaji K. Kumar, Ola Landgren, Nikhil C. Munshi, Michele Cavo, Faith E. Davies, Alessandra Di Bacco, Jennifer S. Dickey, Steven I. Gutman, Howard R. Higley, Mohamad A. Hussein, J. Milburn Jessup, Ilan R. Kirsch, Richard F. Little, Robert D. Loberg, Jens G. Lohr, Lata Mukundan, James L. Omel, Trevor J. Pugh, Gregory H. Reaman, Michael D. Robbins, A. Kate Sasser, Nancy Valente, Elena Zamagni
    Clinical Cancer Research Aug 2017, 23 (15) 3980-3993; DOI: 10.1158/1078-0432.CCR-16-2895
  • FDA's Approach to Regulating Biosimilars
    Steven J. Lemery, M. Stacey Ricci, Patricia Keegan, Amy E. McKee, Richard Pazdur
    Clinical Cancer Research Apr 2017, 23 (8) 1882-1885; DOI: 10.1158/1078-0432.CCR-16-1354

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