Ensuring that accelerated approvals benefit patients [PDF]
The Lancet Haematology, 2021 The Lancet Haematology
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PLoS ONE, 2020 Regulatory agencies around the world have been using flexible requirements for approval of new drugs, especially for cancer drugs. The US Food and Drug Administration (FDA) is mostly the first agency to approve new drugs worldwide, mainly due to the ...
Tatiane Bomfim Ribeiro +3 more
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Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval. [PDF]
JAMA Oncol, 2023 Parikh RB +6 more
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Monkeypox, smallpox, FDA, and accelerated approval of vaccines - A regulatory perspective. [PDF]
Vaccine, 2023 Sun WMD.
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Physician Perspectives on the Food and Drug Administration's Decision to Grant Accelerated Approval to Aducanumab for Alzheimer's Disease. [PDF]
Clin Pharmacol Ther, 2023 Dhruva SS +6 more
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The value of the accelerated approval pathway: real-world outcomes associated with reducing the time between innovations. [PDF]
Future OncolWong W +6 more
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Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation. [PDF]
BMJ MedNaci H +6 more
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Medicare Spending on Drugs With Accelerated Approval, 2015-2019. [PDF]
JAMA Health Forum, 2021 Rome BN, Feldman WB, Kesselheim AS.
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Analysis of FDA's Accelerated Approval Program Performance December 1992-December 2021. [PDF]
Ther Innov Regul Sci, 2022 Beakes-Read G +3 more
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