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   Articles with "approval" as a keyword



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An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.

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recommendations! 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
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Association of Infectious Disease Physician Approval of Peripherally Inserted Central Catheter With Appropriateness and Complications

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recommendations! 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

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recommendations! 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

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recommendations! 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

Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA

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recommendations! Published in 2025 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2025.2026

Abstract: Key Points Question What factors are associated with the fast conversion of accelerated Food and Drug Administration approval of cancer drugs to regular approval? Findings In this cohort study of 102 cancer drug indications granted… read more here.

Keywords: granted accelerated; accelerated approval; time full; factors time ... See more keywords

Prescribing Changes After Accelerated vs Regular Approval of Oncology Therapies.

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recommendations! Published in 2025 at "JAMA network open"

DOI: 10.1001/jamanetworkopen.2025.20726

Abstract: This cross-sectional study analyzes prescribing practices for oncologic drugs following US Food and Drug Administration accelerated approval or regular approval. read more here.

Keywords: oncology; changes accelerated; approval; prescribing changes ... See more keywords

Global system for cancer drug testing and approval is needed

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recommendations! 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

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recommendations! 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

Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets

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recommendations! Published in 2025 at "Clinical Pharmacology and Therapeutics"

DOI: 10.1002/cpt.3562

Abstract: Japan's conditional/time‐limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between… read more here.

Keywords: conditional time; japan conditional; approval; medicine ... See more keywords

Quality of biomarker defined subgroups in FDA approvals of PD‐1/PD‐L1 inhibitors 2014 to 2020

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recommendations! Published in 2022 at "International Journal of Cancer"

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

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recommendations! 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