Cargando…

Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program

This quality improvement study compares US Food and Drug Administration accelerated approvals with Canadian health and technology assessment approvals and timelines for malignant hematology and oncology treatments.

Detalles Bibliográficos
Autores principales:	Ho, Cheryl, Lim, Howard J., Regier, Dean A.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2021
Materias:	Research Letter
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8358729/ https://www.ncbi.nlm.nih.gov/pubmed/34379128 http://dx.doi.org/10.1001/jamanetworkopen.2021.20301

Ejemplares similares

FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
por: Ho, Cheryl, et al.
Publicado: (2022)

US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018
por: Omae, Kenji, et al.
Publicado: (2022)

Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
por: Hutchinson, Nora, et al.
Publicado: (2021)

US Food and Drug Administration regulatory updates in neuro-oncology
por: Mehta, Gautam U., et al.
Publicado: (2021)

Routes of administration, reasons for use, and approved indications of medical cannabis in oncology: a scoping review
por: Vinette, Billy, et al.
Publicado: (2022)

Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
por: Parikh, Ravi B., et al.
Publicado: (2023)

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
por: Cherla, Avi, et al.
Publicado: (2021)

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
por: Egilman, Alexander, et al.
Publicado: (2021)

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
por: Sachs, Rachel E., et al.
Publicado: (2021)

Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
por: Yang, Derek Z., et al.
Publicado: (2021)

Enrollment of Black Participants in Pivotal Clinical Trials Supporting US Food and Drug Administration Approval of Chimeric Antigen Receptor–T Cell Therapy for Hematological Malignant Neoplasms
por: Al Hadidi, Samer, et al.
Publicado: (2022)

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review
por: Sochacka-Ćwikła, Aleksandra, et al.
Publicado: (2021)

Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020
por: Miljković, Miloš D., et al.
Publicado: (2022)

Nanomedicine approaches for treatment of hematologic and oncologic malignancies
por: Nteli, Polyxeni, et al.
Publicado: (2022)

US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera M., et al.
Publicado: (2023)

Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU
por: Demirci, Ebru, et al.
Publicado: (2023)

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
por: Xie, Jinping, et al.
Publicado: (2023)

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera, et al.
Publicado: (2021)

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications
por: Lee, Samuel J., et al.
Publicado: (2021)

Overview of the Side-Effects of FDA- and/or EMA-Approved Targeted Therapies for the Treatment of Hematological Malignancies
por: Constantinescu, Catalin, et al.
Publicado: (2020)

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
por: Jiao, Kuo, et al.
Publicado: (2019)

Time for the US food and drug administration approval of condoms for anal intercourse
por: Nguyen, Brian T., et al.
Publicado: (2019)

Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration
por: Feldman, Daniel, et al.
Publicado: (2022)

The Impact of an Embedded Oncology Pharmacist in an Outpatient Oncology Center in the Treatment of Hematologic Malignancies
por: Mae Trinidad, Denisse, et al.
Publicado: (2022)

Regulatory T Cells and Their Prognostic Relevance in Hematologic Malignancies
por: D'Arena, Giovanni, et al.
Publicado: (2017)

Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests
por: Yang, Tony, et al.
Publicado: (2022)

Monkeypox, smallpox, FDA, and accelerated approval of vaccines – A regulatory perspective
por: Sun, Wellington
Publicado: (2023)

Hematology and Oncology in Critical Illness
por: Brandão, Leonardo R., et al.
Publicado: (2011)

A perspective on life-cycle health technology assessment and real-world evidence for precision oncology in Canada
por: Regier, Dean A., et al.
Publicado: (2022)

PET-CT in Clinical Adult Oncology: I. Hematologic Malignancies
por: Salem, Ahmed Ebada, et al.
Publicado: (2022)

Herpes Zoster Vaccination Rates in Hematological and Oncological Patients—Stock Taking 2 Years after Market Approval
por: Kiderlen, Til Ramón, et al.
Publicado: (2022)

Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
por: Wallach, Joshua D., et al.
Publicado: (2021)

U.S. Food and Drug Administration: Review for the Emergency Physician of Approval Process and Limitations
por: Zuabi, Nadia, et al.
Publicado: (2016)

Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
por: Liang, Fei, et al.
Publicado: (2020)

Review of Evidence Supporting 2022 US Food and Drug Administration Drug Approvals
por: Kaplan, Robert M., et al.
Publicado: (2023)

US Supercollider approved
Publicado: (1987)

Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021
por: Lau, Catherine, et al.
Publicado: (2022)

Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals
por: Lammers, Austin, et al.
Publicado: (2017)

Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
por: Lemery, Steven, et al.
Publicado: (2022)

Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011–2017: Lessons Learned for Anticancer Drug Development
por: Faucette, Stephanie, et al.
Publicado: (2017)

Cannot write session to /tmp/vufind_sessions/sess_h5smjr69bv2f3v2vushrcohumb