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References from US Food and Drug Administration Officials’ Public Statements on Regulatory Flexibility in New Drug Approval, 2021–2024. Local targets link to admitted publications; unresolved targets remain external evidence.
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10.1093/haschl/qxaf183
10.1093/haschl/qxaf183 · External reference
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10.1001/jama.2024.5613
10.1001/jama.2024.5613 · External reference
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10.1001/jama.2025.24532
10.1001/jama.2025.24532 · External reference
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10.1056/nejmsb2512695
10.1056/nejmsb2512695 · External reference
10.1001/jama.2022.22566
10.1001/jama.2022.22566 · External reference
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10.1056/nejmp2104846
10.1056/nejmp2104846 · External reference
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10.1056/nejmp2110468
10.1056/nejmp2110468 · External reference
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10.1001/jama.2025.10116
10.1001/jama.2025.10116 · External reference
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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug
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6 Ways the FDA’s Approval of Aduhelm Does More Harm than Good
2021 · External reference
10.1001/jama.2025.21721
10.1001/jama.2025.21721 · External reference
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10.1001/jamanetworkopen.2025.2040
10.1001/jamanetworkopen.2025.2040 · External reference
Accelerated Removal: FDA Making Use of New Authority to Withdraw Ineffective Drugs More Quickly
2024 · External reference
10.1177/1740774518770648
10.1177/1740774518770648 · External reference
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Diffusing Authority to Make Drug Approval Decisions at the US Food and Drug Administration
10.1038/s41591-025-03948-5 · 2025 · External reference
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10.1001/jama.2024.4175
10.1001/jama.2024.4175 · External reference
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10.1146/annurev-med-051022-043645
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