Zobrazeno 1 - 10
of 30
pro vyhledávání: '"Kevin J, Weatherwax"'
Autor:
Misty Gravelin, Laurie Rigan, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 150-151 (2024)
OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only. We sought to evaluate these requests
Externí odkaz:
https://doaj.org/article/c1256fd7fe614fc9afbe3824224a7daf
Autor:
Misty Gravelin, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax, Laurie Rigan
Publikováno v:
Journal of Clinical and Translational Science, Vol 8, Pp 152-152 (2024)
OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Acce
Externí odkaz:
https://doaj.org/article/5ef196caa6b34c8b91bb280627074757
Autor:
Misty Gravelin, Joan E. Adamo, Sharon Ellison, Erika Segear, Amanda B. Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan, George A. Mashour, Kevin J. Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 7 (2023)
Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic me
Externí odkaz:
https://doaj.org/article/0f8891b01794433285895cb2b0fb2ca8
Autor:
Misty Gravelin, Jeanne Wright, M.E. Blair Holbein, Marlene Berro, Jennifer S. Brown, George A. Mashour, Kevin J. Weatherwax
Publikováno v:
Journal of Clinical and Translational Science, Vol 5 (2021)
Abstract Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergen
Externí odkaz:
https://doaj.org/article/1230133a4dd1470c8f796da359c760e4
Autor:
M. E. Blair Holbein, Kevin J. Weatherwax, Misty Gravelin, Raymond Hutchinson, George A. Mashour
Publikováno v:
Journal of Clinical and Translational Science, Vol 2, Pp 115-117 (2018)
Externí odkaz:
https://doaj.org/article/96dae814ae954fc6ab9667303a413125
Autor:
Misty Gravelin, Joan E. Adamo, Sharon Ellison, Erika Segear, Amanda B. Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan, George A. Mashour, Kevin J. Weatherwax
Publikováno v:
Journal of Clinical and Translational Science. 7
Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic me
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8f3668d0759c57698b9ee8bf2d58ca07
https://doi.org/10.1017/cts.2022.494
https://doi.org/10.1017/cts.2022.494
Publikováno v:
Am J Bioeth
Webb et al. (2020) propose a novel process regarding how to prioritize the allocation of COVID-19 drugs via emergency use authorization (EUA) and pre-approval access (PAA) pathways such as Expanded...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d5597ca57c71efeebd0a95a9533bd29
https://doi.org/10.1080/15265161.2020.1795546
https://doi.org/10.1080/15265161.2020.1795546
Autor:
Marlene Berro, Jennifer Swanton Brown, George A. Mashour, Kevin J. Weatherwax, Misty Gravelin, Jeanne Wright, M. E. Blair Holbein
Publikováno v:
Journal of Clinical and Translational Science
Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Aut
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc5f87e2e0a3017c5f42e889e0a19566
http://europepmc.org/articles/PMC8134898
http://europepmc.org/articles/PMC8134898
Autor:
George Samson, Thomas Carrigan, Kevin J. Weatherwax, Charles Newman, Archie C Brown, Denis Foo Kune, Balasundaram Lavan, Kim A. Eagle, Nathan Sovitch, Ed Goldman, Hakan Oral, Daniel Alyesh, Thomas Crawford, Sandra Lach Arlinghaus, Craig Allmendinger, Andrew B. Hughey, Timir S. Baman, Sheldon Davis, Karman Tandon, Jay Snell, Pat Sovitch, Daniel Lautenbach, Noah Klugman, Brad Wasserman
Publikováno v:
JACC: Clinical Electrophysiology. 3:623-631
Objectives This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). Background Access to cardiac CIED therapy in high-income and in low-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1d968f9fc0208b4f4a0c7150176c56ab
https://doi.org/10.1016/j.jacep.2016.12.007
https://doi.org/10.1016/j.jacep.2016.12.007
Publikováno v:
Otolaryngol Head Neck Surg
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::303f20559750fc27fe95d7ca7acb17a3
https://pubmed.ncbi.nlm.nih.gov/31874066
https://pubmed.ncbi.nlm.nih.gov/31874066