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Journal Articles

Updates in Clinical Data on FDA Fast Track Drugs for Relapsed Refractory Multiple Myeloma: A Systematic Review of Literature

Muhammad Abdullah Yousaf, MBBS, MD, Muhaddis Ejaz Ahmad, MD, Maaz Ahmed Yusufi, MD, Asim Tameez ud din, MD, Muhammad Qudrat Ullah, MD, Muhammad Yasir Anwar, MD, Abdul Rafae, MD, Mustafa Nadeem Malik, MD, Zunairah Shah, MBBS, Ahmed Ibrahim, Faiz Anwer, MD

Blood (2019) 134 (Supplement_1): 5579.

https://doi.org/10.1182/blood-2019-123296

Published: 2019

Journal Articles

Fulfillment of Postmarketing Commitments for Novel Malignant Hematology Products Granted Accelerated Approval By the FDA between 2011-2016

Marjorie E Zettler, PhD MPH, Chadi Nabhan, MD MBA, FACP

Blood (2017) 130 (Supplement 1): 4712.

https://doi.org/10.1182/blood.V130.Suppl_1.4712.4712

Published: 2017

Journal Articles

Analysis of Drugs for Hematological Malignancy That Were Granted Accelerated Approval and Feasibility of Randomized Phase 3 Clinical Trials for Relapsed and Refractory Hematological Malignancy

Sumimasa Nagai, MD, PhD, Keiya Ozawa, MD PhD

Blood (2016) 128 (22): 2387.

https://doi.org/10.1182/blood.V128.22.2387.2387

Published: 2016

Journal Articles

A Complementary Role of High Throughput Sequencing and Multiparameter Cytometry for Minimal Residual Disease (MRD) Detection in Chronic Lymphocytic Leukemia (CLL):an European Research Initiative (ERIC) Study

Andy Rawstron, PhD, Claudia Fazi, PhD, Neus Villamor, MD PhD, Julio Delgado, MD PhD, Remi Letestu, MD PhD, Florence Cymbalista, MD, Carlos Palacio, Francesc Bosch, MD PhD, Ruth M De Tute, MSc, Stuart Liptrot, David O'Brien, FAMLs, Martin Spacek, MD, PhD, Johan Dobber, Arnon P. Kater, MD PhD, Peter C Gambell, David A Westerman, MBBS, FRACP, FRCPA, Asha Soosapilla, Stephen P. Mulligan, MBBS, PhD FRACP, FRCPA, Gerard Lozanski, MD, Ke Lin, PhD, Andrew R Pettitt, MRCP, PhD, Gabi Brachtl, Alexander Egle, MD, David W Williamson, PhD, Catherine M Sanders, PhD, Harlan Robins, PhD, Justin Boysen, Tait D. Shanafelt, MD, Curtis A. Hanson, MD, Jeffrey L. Jorgensen, MD PhD, William G. Wierda, MD PhD, Constance Yuan, MD PhD, Maryalice Stetler-Stevenson, MD PhD, Laura Rassenti, PhD, H. Elizabeth Broome, MD, Thomas J. Kipps, MD PhD, Mathieu Hauwel, Iuri Marinov, Fiona E. Craig, MBBS, Nomdedeu Josep, Carol Moreno, MD, Olga Stehlikova, MSc., Michael Doubek, Sarka Pospisilova, Prof., Dr., PhD, Karl-Anton Kreuzer, MD, Michael Hallek, MD, Peter Hillmen, MBChB, PhD, Emili Montserrat, MD PhD, Paolo Ghia, MD

Blood (2014) 124 (21): 1976.

https://doi.org/10.1182/blood.V124.21.1976.1976

Published: 2014

Journal Articles

When it comes to MRD, AML ≠ ALL

Elisabeth Paietta

Blood (2012) 120 (8): 1536–1537.

https://doi.org/10.1182/blood-2012-06-435081

Published: 2012

Journal Articles

Waiting for Godot: Thirty-Six Month Follow-Up on Accelerated FDA Approval of Drugs To Treat Hematologic Malignancies.

Veena Shankaran, MD, June McKoy, MD, MPH, JD, Ben Djulbegovic, MD, PhD, Allison Lyons, BA, Ken Carson, MD, Cara Tigue, BA, Neal Dandade, BA, Martin Tallman, MD, Oliver Sartor, MD, Charles Bennett, MD, PhD, MPP

Blood (2007) 110 (11): 3340.

https://doi.org/10.1182/blood.V110.11.3340.3340

Published: 2007

Journal Articles

2006 RADAR Report Card on Conversion Rates from Accelerated FDA Approval to Regular FDA Approval for Drugs Used To Treat Hematologic Malignancies: Policy Changes Continue To Be Needed.

Andrew J. Lurie, BGS, Mark V. Mai, Martin S. Tallman, MD, June McCoy, MD JD MPH, Charles L. Bennett, MD PhD MPP

Blood (2006) 108 (11): 3318.

https://doi.org/10.1182/blood.V108.11.3318.3318

Published: 2006

Journal Articles

2005 Update on Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies from the Research on Adverse Drug-Events and Reports (RADAR): Rate of Regular Approval Conversion Remains Low.

Charles L. Bennett, MD, PhD, MPP, Jessica A. Zagory, BA, June M. McKoy, MD, MPH, JD, Kathryn R. McCaffrey, BA, E. Allison Lyons, BA, Steven Belknap, MD

Blood (2005) 106 (11): 289.

https://doi.org/10.1182/blood.V106.11.289.289

Published: 2005

Journal Articles

Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies: Are Policy Changes Needed?.

Elizabeth A. Lyons, BA, June M. McKoy, MD, JD, MPH, Steven Belknap, MD, Kenneth R. Carson, MD, Charles L. Bennett, MD, PhD

Blood (2004) 104 (11): 266.

https://doi.org/10.1182/blood.V104.11.266.266

Published: 2004

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Updates in Clinical Data on FDA Fast Track Drugs for Relapsed Refractory Multiple Myeloma: A Systematic Review of Literature

Fulfillment of Postmarketing Commitments for Novel Malignant Hematology Products Granted Accelerated Approval By the FDA between 2011-2016

Analysis of Drugs for Hematological Malignancy That Were Granted Accelerated Approval and Feasibility of Randomized Phase 3 Clinical Trials for Relapsed and Refractory Hematological Malignancy

A Complementary Role of High Throughput Sequencing and Multiparameter Cytometry for Minimal Residual Disease (MRD) Detection in Chronic Lymphocytic Leukemia (CLL):an European Research Initiative (ERIC) Study

When it comes to MRD, AML ≠ ALL

Waiting for Godot: Thirty-Six Month Follow-Up on Accelerated FDA Approval of Drugs To Treat Hematologic Malignancies.

2006 RADAR Report Card on Conversion Rates from Accelerated FDA Approval to Regular FDA Approval for Drugs Used To Treat Hematologic Malignancies: Policy Changes Continue To Be Needed.

2005 Update on Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies from the Research on Adverse Drug-Events and Reports (RADAR): Rate of Regular Approval Conversion Remains Low.

Accelerated FDA Approval of Drugs Used To Treat Hematologic Malignancies: Are Policy Changes Needed?.

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