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 +4 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
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
doaj +4 more sources
Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality [PDF]
Clinical and Translational ScienceWhile the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy ...
Maho Iwata, Anju Murayama
doaj +2 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 +2 more sources
Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway [PDF]
Journal of Pharmaceutical Policy and PracticeBackground Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited ...
Mahnum Shahzad +4 more
doaj +2 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 +2 more sources
Accelerated drug approval: Meeting the ethical yardstick [PDF]
Bioethics, 2023 AbstractDrugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S.
Mattia Andreoletti, Alessandro Blasimme
openalex +3 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 +2 more sources
Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022 [PDF]
BMC MedicineBackground The Food and Drug Administration (FDA)’s Accelerated Approval (AA) pathway has increasingly used to authorize market approval of new drugs amid controversy.
Xiaofang Zhang +8 more
doaj +2 more sources