A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics-Reference-Cited by-同舟云学术

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

Published:2018-06-01 Issue:6 Volume:4 Page:849
ISSN:2374-2437
Container-title:JAMA Oncology
language:en
Short-container-title:JAMA Oncol

Author:

Beaver Julia A.¹,Howie Lynn J.¹,Pelosof Lorraine¹,Kim Tamy²,Liu Jinzhong¹,Goldberg Kirsten B.¹,Sridhara Rajeshwari³,Blumenthal Gideon M.¹,Farrell Ann T.¹,Keegan Patricia¹,Pazdur Richard²,Kluetz Paul G.²

Affiliation:

1. Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland

2. Center for Drug Evaluation and Research and Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland

3. Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference21 articles.

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2. Accelerated approval of oncology products: the Food and Drug Administration experience.;Johnson;J Natl Cancer Inst,2011

3. End points and United States Food and Drug Administration approval of oncology drugs.;Johnson;J Clin Oncol,2003

4. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration.;Naci;JAMA,2017

5. Physicians’ knowledge about FDA approval standards and perceptions of the “breakthrough therapy” designation.;Kesselheim;JAMA,2016

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