Cargando…

US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine

Detalles Bibliográficos
Autor principal:	Dal-Ré, Rafael
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Elsevier Ltd. 2021
Materias:	Commentary
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7817401/ https://www.ncbi.nlm.nih.gov/pubmed/33516602 http://dx.doi.org/10.1016/j.vaccine.2021.01.050

Ejemplares similares

Current COVID-19 vaccine trials in high-income countries: are placebo-controlled trials ethical?
por: Dal-Ré, Rafael, et al.
Publicado: (2021)

First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use Authorization
por: Fortner, Andra, et al.
Publicado: (2021)

Placebo-controlled trials with COVID-19 vaccines: participants first
por: Dal-Ré, Rafael
Publicado: (2021)

Erratic Flu Vaccination Emerges from Short-Sighted Behavior in Contact Networks
por: Cornforth, Daniel M., et al.
Publicado: (2011)

Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation Approaches
por: Zariffa, Névine, et al.
Publicado: (2021)

The menacing assaults on science, FDA, CDC, and health of the US public
por: Alter, Scott M., et al.
Publicado: (2020)

Placebo control group in COVID-19 vaccine trials: context and timing matters
por: Dal-Ré, Rafael
Publicado: (2021)

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways
por: Klein, Kevin, et al.
Publicado: (2021)

Public trust on regulatory decisions: The European Medicines Agency and the AstraZeneca COVID-19 vaccine label
por: Dal-Ré, Rafael, et al.
Publicado: (2021)

When is it reasonable to extrapolate during a pandemic?: The case of broad UK labeling for AstraZeneca COVID-19 vaccine
por: Dal-Ré, Rafael, et al.
Publicado: (2021)

Rhinoscleroma: Report of an Erratic Palatal Swelling
por: Mandale, Mandakini Subhash, et al.
Publicado: (2018)

Safeguarding evidence-based decision making in the FDA for COVID-19 vaccines
por: Angelis, Aris, et al.
Publicado: (2021)

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

The FDA Changed Everything
por: Geantă, Marius, et al.
Publicado: (2017)

Why prudence is needed when interpreting articles reporting clinical trial results in mental health
por: Dal-Ré, Rafael, et al.
Publicado: (2017)

Human Germline Mutation and the Erratic Evolutionary Clock
por: Moorjani, Priya, et al.
Publicado: (2016)

Erratic coil migration in the bronchus after bronchial artery embolization
por: Ishikawa, Hideo, et al.
Publicado: (2019)

FDA's authorized “JYNNEOS” vaccine for counteracting monkeypox global public health emergency; an update – Correspondence
por: Sah, Ranjit, et al.
Publicado: (2022)

Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes
por: Freeman, Michael, et al.
Publicado: (2012)

Clinical Trial Diversity in Oncology: FDA Takes Action with Post–Marketing Requirements or Commitments
por: Kim, Janice, et al.
Publicado: (2022)

A systematic approach to biomarker discovery; Preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers"
por: Butterfield, Lisa H, et al.
Publicado: (2008)

Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
por: Abbas, Nasir, et al.
Publicado: (2021)

The Effects of the FDA Warning on the Use of Droperidol by U.S. Emergency Physicians
por: Richards, John R., et al.
Publicado: (2003)

Inclusion of patient-reported outcome instruments in US FDA medical device marketing authorizations
por: Matts, Sophia T., et al.
Publicado: (2022)

Graptolites from glacial erratics of the Laerheide area, northern Germany
por: Maletz, Jörg, et al.
Publicado: (2017)

Two Erratic Cases of Tinea Capitis in Adults: Utility of Trichoscopy
por: Lahouel, Maha, et al.
Publicado: (2020)

Changes to the extreme and erratic behaviour of cryptocurrencies during COVID-19
por: James, Nick, et al.
Publicado: (2021)

Erratic enteric absorption of dolutegravir in a critically ill patient
por: de Antonio-Cuscó, Marta, et al.
Publicado: (2022)

Errate: Hypoprothrombinemia During Cefmetazole Treatment: A Case Report
por: Haba, Yuichiro, et al.
Publicado: (2022)

New placebo-controlled Covid-19 vaccine trials are ethically questionable; it's now about comparative effectiveness and availability of registered vaccines
por: Knottnerus, J. André
Publicado: (2021)

Public health workforce: challenges and policy issues
por: Beaglehole, Robert, et al.
Publicado: (2003)

Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting
por: Witkowski, Piotr, et al.
Publicado: (2021)

Forty Years of Erratic Insecticide Resistance Evolution in the Mosquito Culex pipiens
por: Labbé, Pierrick, et al.
Publicado: (2007)

CPIS Lung Ultrasound and the Erratic March toward Diagnostic Certainty in VAP
por: Rajagopalan, Ram E
Publicado: (2021)

Erratic and blood vessel-guided migration of astrocyte progenitors in the cerebral cortex
por: Tabata, Hidenori, et al.
Publicado: (2022)

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company
por: Arpinelli, Fabio, et al.
Publicado: (2006)

Emergency Use Authorization for Remdesivir and Its Potential Implications
por: Ochoa Chaar, Cassius Iyad, et al.
Publicado: (2020)

FDA's pathway for regulation of FMT: not so fraught
por: Riley, Margaret F., et al.
Publicado: (2015)

Remdesivir use and outcomes during the FDA COVID-19 emergency use authorization period
por: Elshaboury, Ramy H., et al.
Publicado: (2021)

Further considerations for placebo controls in surgical trials
por: Campbell, Marion K., et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_ploggf01uj0oiskd2pfdreu7ok