Results 11 to 20 of about 1,709,620 (289)
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. [PDF]
JAMA Netw Open, 2021 This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration–required confirmatory clinical trials for the 50 new therapeutic agents that ...
Wallach JD +6 more
europepmc +3 more sources
Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017. [PDF]
JAMA Health Forum, 2022 Key Points Question How much do the Centers for Medicare & Medicaid (CMS) spend on drugs granted accelerated approval by the US Food and Drug Administration (FDA), before and after confirmation of the drug’s benefit?
Skydel JJ +5 more
europepmc +3 more sources
European Journal of Health Economics, 2023 Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track ...
Daniel Tobias Michaeli +4 more
openalex +2 more sources
JAMA Intern Med, 2023 This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US.
Jazowski SA +4 more
europepmc +2 more sources
Analysis of FDA's Accelerated Approval Program Performance December 1992-December 2021. [PDF]
Ther Innov Regul Sci, 2022 The accelerated approval pathway has been criticized recently for employing lower regulatory standards than traditional drug approval, undue delays in withdrawing approvals of drugs for which studies have not confirmed clinical benefit, and confirmatory ...
Beakes-Read G +3 more
europepmc +2 more sources
JAMA Netw Open, 2023 This cross-sectional study evaluates the basis for the supporting evidence and treatment preference ratings for cancer drugs and indications recommended by the National Comprehensive Cancer Network (NCCN) guidelines committees.
Cliff ERS +3 more
europepmc +2 more sources
FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment [PDF]
Current Oncology, 2022 Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011.
Cheryl Ho, Howard J. Lim, Dean A. Regier
doaj +2 more sources
JAMA, 2023 This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.
Shahzad M, Naci H, Wagner AK.
europepmc +2 more sources
JAMA Health Forum, 2023 This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.
Deshmukh AD, Kesselheim AS, Rome BN.
europepmc +2 more sources
JAMA Netw Open, 2022 This cohort study evaluates how the US Food and Drug Administration (FDA) accelerated approval program has been used for nononcology drugs over a period of 26 years.
Omae K, Onishi A, Sahker E, Furukawa TA.
europepmc +2 more sources