A framework for assessing the impact of accelerated approval. [PDF]
PLoS ONE, 2022 The FDA's Accelerated Approval program (AA) is a regulatory program to expedite availability of products to treat serious or life-threatening illnesses that lack effective treatment alternatives.
A Lawrence Gould +10 more
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Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA. [PDF]
JAMA Netw OpenApproval anticancer medicines; Accelerated approvalAprobación de medicamentos anticancerígenos; Aprobación aceleradaAprovació de medicaments anticancerígens; Aprovació acceleradaImportance The accelerated approval pathway was developed to expedite US ...
Tibau A +6 more
europepmc +5 more sources
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval. [PDF]
JAMA Oncol, 2023 This cross-sectional study evaluates patient exposure to oncology drugs withdrawn from the US Food and Drug Administration (FDA) Accelerated Approval program.
Parikh RB +6 more
europepmc +3 more sources
Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU [PDF]
Clinical and Translational Science, 2023 The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug ...
Ebru Demirci +2 more
doaj +3 more sources
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 In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval to aducanumab, a monoclonal antibody indicated for the treatment of Alzheimer's disease.
Dhruva SS +6 more
europepmc +4 more sources
Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits. [PDF]
J Health Polit Policy Law, 2022 Many state Medicaid officials are concerned about rising prescription drug spending, particularly about drugs approved through the Food & Drug Administration's (FDA) accelerated approval pathway.
Sachs RE +4 more
europepmc +4 more sources
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study [PDF]
BMJ MedicineObjectives To evaluate National Comprehensive Cancer Network (NCCN) guideline recommendations for oncology drug treatments that have been granted accelerated approval, and to determine whether recommendations are updated based on the results of ...
Joseph S Ross +5 more
doaj +3 more sources
Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union [PDF]
Frontiers in Medical TechnologyThe landscape of medical device regulation is rapidly evolving, driven by innovations and the need to bring these technologies to patients more efficiently.
Tanvi Gupte +3 more
doaj +4 more sources
Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study [PDF]
BMJ Open, 2023 Objective We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA ...
Yi Chen +8 more
doaj +3 more sources
Medicare Spending on Drugs With Accelerated Approval, 2015-2019. [PDF]
JAMA Health Forum, 2021 This article examines the budgetary implications of high-priced accelerated approval drugs by estimating Medicare spending on these drugs from 2015 through 2019.
Rome BN, Feldman WB, Kesselheim AS.
europepmc +3 more sources