Results 281 to 289 of about 1,709,620 (289)
Some of the next articles are maybe not open access.
The Accelerated Approval Program for Cancer Drugs - Finding the Right Balance.
New England Journal of Medicine, 2023B. Gyawali, A. Kesselheim, Joseph S Ross
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Increasing FDA Accelerated approval of Single-Arm Trials in Oncology (1992 to 2020).
Journal of Clinical Epidemiology, 2023T. Ribeiro +5 more
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The On- and Off-Ramps of Oncology Accelerated Approval.
New England Journal of Medicine, 2022L. Fashoyin-Aje +3 more
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Sotorasib's Accelerated Approval: Wrong Dose and Indication.
JAMA OncologyThis Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRASg12c mutation, and recommends measures to ensure ...
M. Ratain, Aaron S. Kesselheim
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Accelerated Approval - Taking the FDA's Concerns Seriously.
New England Journal of Medicine, 2022R. Sachs, J. Donohue, S. Dusetzina
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Global consequences of the US FDA's accelerated approval of cancer drugs.
The Lancet Oncology, 2022Amol Akhade, B. Sirohi, B. Gyawali
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