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

Author:

Dal-Ré Rafael

Publisher

Elsevier BV

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health,General Veterinary,General Immunology and Microbiology,Molecular Medicine

Reference17 articles.

1. Developing safe and effective covid vaccines—operation warp speed’s strategy and approach;Slaoui;N Engl J Med,2020

2. US Department of Health and Human Services. Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19. Guidance for industry; June 2020. Accessed at https://www.fda.gov/media/139638/download on 16 November 2020.

3. World Medical Association. Declaration of Helsinki – Ethical principles for medical research involving human subjects. In: 64th WMA General Assembly, Fortaleza, Brazil; October 2013. Accessed at https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ on 16 November 2020.

4. US Department of Health and Human Services. Protection of human subjects. 45CFR46-116 General Requirements for Informed consent. Accessed at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1116 on 16 November 2020.

5. US Department of Health and Human Services. Food and Drug Administration. E6(R2) Good clinical practice: integrated addendum to ICH E6(R1). Guidance for industry; March 2018. Accessed at https://www.fda.gov/media/93884/download on 16 November 2020.

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