緊急授權適用緊急標準?——以美國COVID-19 期間疫苗緊急授權為例
曾培琪 - 2023 - tdr.lib.ntu.edu.tw
本文研究主題為美國緊急授權制度下審查COVID-19 疫苗的[緊急標準], 分析在緊急狀態下,
美國是否採取了相較於平常時期更低的標準審酌科學證據. 為了解美國食品藥物管理署(下稱食 …
美國是否採取了相較於平常時期更低的標準審酌科學證據. 為了解美國食品藥物管理署(下稱食 …
[PDF][PDF] COVID-19 疫苗強制接種政策之跨國比較
葉明叡， 歐晁瑋 - 疫情報導, 2022 - cdc.gov.tw
摘要COVID-19 大流行至今, 疫苗接種為最有效的防治策略之一, 但各個社會中,
總存在有除了醫學理由以外, 因不同理由而拒絕接種疫苗的民眾. 在疫苗供應穩定之後 …
總存在有除了醫學理由以外, 因不同理由而拒絕接種疫苗的民眾. 在疫苗供應穩定之後 …
Why emergency COVID vaccine approvals could pose a dilemma
D Cyranoski - Nature, 2020 - nature.com
Once a vaccine is granted emergency approval, there is pressure on developers to offer the
immunization to trial participants who received a placebo. But if too many people cross over …
immunization to trial participants who received a placebo. But if too many people cross over …
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19: Analysis reviews the Food and Drug Administration's critical …
AS Kesselheim, JJ Darrow, M Kulldorff, BL Brown… - Health …, 2021 - healthaffairs.org
The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh
the risks for their intended use. In this article we review the standard FDA approach to …
the risks for their intended use. In this article we review the standard FDA approach to …
Comparison of COVID-19 vaccine approvals at the US Food and Drug administration, European Medicines agency, and health Canada
MP Lythgoe, P Middleton - JAMA Network Open, 2021 - jamanetwork.com
On the 1-year anniversary of the World Health Organization (WHO) declaring COVID-19 a
global pandemic, the development and rollout of safe and effective vaccines has fueled …
global pandemic, the development and rollout of safe and effective vaccines has fueled …
[HTML][HTML] The emergency use authorization of pharmaceuticals: history and utility during the COVID-19 pandemic
A Tran, TJ Witek Jr - Pharmaceutical Medicine, 2021 - Springer
Abstract The Emergency Use Authorization (EUA) originated in 2004 because of the need
for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The …
for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The …
Every Minute Matters: Improving the Regulatory Response to Vaccine Development During a Public Health Emergency
R Borah - Food & Drug LJ, 2020 - HeinOnline
In recent months, our lives have been turned upside down by the novel coronavirus (COVID-
19) emergency. With no cure or vaccine in sight, millions of people have contracted the …
19) emergency. With no cure or vaccine in sight, millions of people have contracted the …
Vaccine safety–is the SARS-CoV-2 vaccine any different?
N Tau, D Yahav, D Shepshelovich - Human Vaccines & …, 2021 - Taylor & Francis
Vaccines have changed modern medicine, and are a mainstay in reducing morbidity and
mortality from infections. Our research group recently published a study in which we found …
mortality from infections. Our research group recently published a study in which we found …
Did the FDA understaff its review of the Pfizer/BioNTech vaccine?
P Doshi, M Herder - 2020 - digitalcommons.schulichlaw.dal.ca
In what is arguably the most important decision the Food and Drug Administration has made
this year—its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine—the …
this year—its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine—the …
[引用][C] 疫苗之研發, 採購與安全性評估政策研議: 由COVID-19 看新興傳染病加速疫苗研發政策建言= Policy recommendation for vaccine development, procurement, and …
疫苗之研發 - (No Title) - cir.nii.ac.jp
疫苗之研發,採購與安全性評估政策研議: 由COVID-19看新興傳染病加速疫苗研發政策建言=
Policy recommendation for vaccine development, procurement, and safety evaluation : using …
Policy recommendation for vaccine development, procurement, and safety evaluation : using …