An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2019.0583
Abstract: Importance Approximately one-third of cancer drugs are approved based on response rate (RR)-the percentage of patients whose tumors shrink beyond an arbitrary threshold-typically assessed in a single-arm study. Objective To characterize RR end points used… read more here.
Keywords: cancer drugs; response; drug; rate ... See more keywords
Association of Infectious Disease Physician Approval of Peripherally Inserted Central Catheter With Appropriateness and Complications
Sign Up to like & getrecommendations! Published in 2020 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2020.17659
Abstract: Key Points Question Is approval by an infectious disease physician prior to placement of a peripherally inserted central catheter (PICC) for intravenous antimicrobials associated with appropriate device use or complications? Findings In this cohort study… read more here.
Keywords: infectious disease; peripherally inserted; inserted central; disease physician ... See more keywords
Knowledge and Attitudes Concerning Aducanumab Among Older Americans After FDA Approval for Treatment of Alzheimer Disease
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2021.48355
Abstract: This survey study examines the understanding of aducanumab and attitudes toward its potential outcomes among older Americans after the drug's approval by the US Food and Drug Administration (FDA) for the treatment for Alzheimer disease. read more here.
Keywords: among older; approval; alzheimer disease; treatment alzheimer ... See more keywords
Association Between Food and Drug Administration Approval and Disparities in Immunotherapy Use Among Patients With Cancer in the US
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.19535
Abstract: Key Points Question Is drug approval by the Food and Drug Administration (FDA) associated with a reduction in disparities in novel cancer treatment use among patients with cancer in the US? Findings In this cohort… read more here.
Keywords: immunotherapy use; cancer; food drug; approval ... See more keywords
Global system for cancer drug testing and approval is needed
Sign Up to like & getrecommendations! Published in 2023 at "Cancer"
DOI: 10.1002/cncr.34668
Abstract: I t is an unfortunate reality that not all patients with cancer have access to the drugs that could effectively treat their disease. Creating and implementing a global system for testing and approving cancer therapies… read more here.
Keywords: system; approval; cancer drugs; global system ... See more keywords
Adherence to evidence‐based surgical metrics improves outcomes in lung cancer
Sign Up to like & getrecommendations! Published in 2023 at "Cancer"
DOI: 10.1002/cncr.34831
Abstract: 1627 such as progression-free survival or overall survival and are limited in assessing safety. Nevertheless, Dr Agrawal believes that oncologists can have confidence in the approvals based on single-arm studies. “Many approvals based on single-arm… read more here.
Keywords: oncology; approval; arm; single arm ... See more keywords
Quality of biomarker defined subgroups in FDA approvals of PD‐1/PD‐L1 inhibitors 2014 to 2020
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DOI: 10.1002/ijc.33968
Abstract: PD‐L1 expression is associated with differential response in cancers treated with checkpoint inhibitors. Clinical trials for Food and Drug Administration (FDA) approvals of programmed death receptor‐1 (PD‐1)/programmed death ligand‐1 (PD‐L1) inhibitors include limited subgroup analyses… read more here.
Keywords: approval; fda approvals; biomarker; clinical trials ... See more keywords
Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Tissue Engineering and Regenerative Medicine"
DOI: 10.1002/term.2428
Abstract: Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less… read more here.
Keywords: medicine; expedited approval; legislation expedited; approval ... See more keywords
Challenges of securing insurance approval for oral tofacitinib for the treatment of alopecia areata: a multi-institution retrospective review
Sign Up to like & getrecommendations! Published in 2021 at "Archives of Dermatological Research"
DOI: 10.1007/s00403-020-02158-y
Abstract: Alopecia areata (AA) is a psychologically distressing disorder for which few reliable treatments exist. Although oral tofacitinib has demonstrated efficacy in treating AA, it is not approved by the Food and Drug Administration (FDA) for… read more here.
Keywords: oral tofacitinib; tofacitinib; insurance approval; approval ... See more keywords
Disability Determination Under Social Security: Increasing Rates of Approval
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DOI: 10.1007/s10597-018-0334-9
Abstract: Supplemental security income (SSI), is the lifeline for our patients living in the community. Absent disability benefits most of our patients are homeless. Many will be hungry, poorly clothed, and have only rudimentary health care.… read more here.
Keywords: determination social; disability; security; disability determination ... See more keywords
Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA
Sign Up to like & getrecommendations! Published in 2022 at "Investigational New Drugs"
DOI: 10.1007/s10637-022-01227-5
Abstract: Background. Previous research focused on the clinical evidence supporting new cancer drugs’ initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives.… read more here.
Keywords: cancer drugs; targeted cancer; approval; indication ... See more keywords