United States Food and Drug Administration and the Pharmaceutical Industry [PDF]
Jane Garland
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United States Food and Drug Administration approved oral kinase inhibitors for the treatment of malignancies [PDF]
The United States Food and Drug Administration (FDA) has approved 19 oral kinase inhibitors (KIs) for the treatment of malignancies in hematology and oncology as of May 2013, see Table 1. We review the general principles and guidelines for using KIs for cancer treatment. This article is not designed for cross-trial comparison or to make recommendations
Woondong Jeong+2 more
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An introspection of quality of novel drug approvals by United States Food and Drug Administration
Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance ...
Ajay Kumar Shukla, Rekha Mehani
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United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy [PDF]
Robert C. Kane+3 more
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Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022. [PDF]
Zhang X+8 more
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Intraspinal steroids: history, efficacy, accidentality, and controversy with review of United States Food and Drug Administration reports [PDF]
Dewey A. Nelson
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United States Food and Drug Administration Regulation of Clinical Software in the Era of Artificial Intelligence and Machine Learning. [PDF]
Singh V, Cheng S, Kwan AC, Ebinger J.
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Abemaciclib-associated kidney injuries: A retrospective analysis of the United States Food and Drug Administration adverse events reporting system. [PDF]
Xu X+7 more
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Comparison of Adverse Events Among Angiotensin Receptor Blockers in Hypertension Using the United States Food and Drug Administration Adverse Event Reporting System. [PDF]
Ogura T, Shiraishi C.
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Data from the United States Food and Drug Administration
Jenny Zheng
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