Results 231 to 240 of about 159,613 (271)
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“Dangling” Accelerated Approvals in Oncology
New England Journal of Medicine, 2021“Dangling” Accelerated Approvals in Oncology The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing that for 10 indi...
Julia A, Beaver, Richard, Pazdur
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Mixed View of “Dangling” Accelerated Approvals
Cancer Discovery, 2021Abstract A changing treatment landscape prompted members of the FDA's Oncologic Drugs Advisory Committee to recommend withdrawing accelerated approvals for two PD-1 inhibitors. The same panel, however, voted to maintain four other accelerated approvals after confirmatory trials showed signs, albeit not statistically significant, of ...
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Medicare Spending on Drugs With Accelerated Approval
Annals of Internal Medicine, 2022The U.S. Food and Drug Administration provides accelerated approval to drugs on the basis of surrogate end points deemed to be "reasonably likely" to predict clinical benefit. To receive full approval, drugs must complete a confirmatory trial. Although most accelerated approved drugs ultimately receive full approval, others remain on the market without
Jeromie Ballreich +6 more
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Accelerated Approval — Taking the FDA’s Concerns Seriously
New England Journal of Medicine, 2022As the U.S. Congress debates a must-pass bill reauthorizing Food and Drug Administration (FDA) user fees for drug and device companies, the future of the FDA’s accelerated-approval program has become a focus of policy discussion. This debate was amplified in part by the agency’s controversial approval in June 2021 of the Alzheimer’s disease drug ...
Sachs, Rachel +2 more
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Accelerated approvals under the microscope
Nature Reviews Drug Discovery, 2021‘Dangling’ accelerated approvals for immuno-oncology antibodies are raising questions about the future of this 30-year-old regulatory programme. ‘Dangling’ accelerated approvals for immuno-oncology antibodies are raising questions about the future of this 30-year-old regulatory programme.
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Accelerating drug development and approval
Drug News & Perspectives, 2010Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority ...
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Sotorasib’s Accelerated Approval
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 confirmatory follow-up studies.
Mark J, Ratain, Aaron S, Kesselheim
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Accelerated Approval of 17α-Hydroxyprogesterone Caproate
Obstetrics & Gynecology, 2020Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U.S. Food and Drug Administration (FDA) approved a commercial version of 17P (trade name “Makena”) through their Accelerated Approval Program, and the ...
Bethany J, Godlewski +3 more
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2009
syn. fast track procedure; approval of therapies “that provide a meaningful therapeutic benefit for patients with serious illness” (FDA) will be accelerated; a similar procedure exist in the EC; in this case, approval relies solely or in part on surrogate endpoints for evidence of effectiveness; the average duration for marketing authorisation in the ...
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syn. fast track procedure; approval of therapies “that provide a meaningful therapeutic benefit for patients with serious illness” (FDA) will be accelerated; a similar procedure exist in the EC; in this case, approval relies solely or in part on surrogate endpoints for evidence of effectiveness; the average duration for marketing authorisation in the ...
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Accelerated approval of drugs: ethics versus efficacy
Indian Journal of Medical Ethics, 2017To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile.This observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website of United States Food and Drug Administration (FDA).
Krishnan V, Chary, Kumaresh, Pandian
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