Results for 'FDA'

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  1. The FDA Ought to Change Plan B’s Label.Christopher ChoGlueck - 2022 - Contraception 106.
    This commentary defends 3 arguments for changing the label of levonorgestrel-based emergency contraception (LNG EC) so that it no longer supports the possibility of a mechanism of action after fertilization. First, there is no direct scientific evidence confirming any postfertilization mechanisms. Second, despite the weight of evidence, there is still widespread public misunderstanding over the mechanism of LNG EC. Third, this FDA label is not a value-free claim, but instead it has functioned like a political tool for reducing contraceptive access. (...)
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  2. E-Cigarettes and the Multiple Responsibilities of the FDA.Larisa Svirsky, Dana Howard & Micah L. Berman - 2021 - American Journal of Bioethics 22 (10):5-14.
    This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA’s obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the (...)
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  3. Fair allocation of scarce therapies for COVID-19.Govind Persad, Monica E. Peek & Seema K. Shah - 2021 - Clinical Infectious Diseases 18:ciab1039.
    The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (...)
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  4. Between Reason and Coercion: Ethically Permissible Influence in Health Care and Health Policy Contexts.J. S. Blumenthal-Barby - 2012 - Kennedy Institute of Ethics Journal 22 (4):345-366.
    In bioethics, the predominant categorization of various types of influence has been a tripartite classification of rational persuasion (meaning influence by reason and argument), coercion (meaning influence by irresistible threats—or on a few accounts, offers), and manipulation (meaning everything in between). The standard ethical analysis in bioethics has been that rational persuasion is always permissible, and coercion is almost always impermissible save a few cases such as imminent threat to self or others. However, many forms of influence fall into the (...)
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  5. Over-the-Counter Oral Contraceptives in the Context of State Abortion Bans.Hunter Jackson Smith, Jake Earl & Elizabeth Lanphier - 2024 - Journal of General Internal Medicine 39:1236–1238.
    The Food and Drug Administration (FDA) recently issued its first approval of an oral contraceptive medication for access without a clinician’s prescription. One might expect this will lead to fewer people seeking to terminate unplanned pregnancies, including in states that imposed severe restrictions on abortion care following the Supreme Court’s reversal on abortion rights in Dobbs v. Jackson Women’s Health Organization. Despite the clear potential health benefits, increased accessibility of oral contraceptives offers no real solution to ongoing threats to patients’ (...)
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  6. A Defence of Pharmaceutical Paternalism.David Teira - 2020 - Journal of Applied Philosophy 37 (4):528-542.
    Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty about an experimental treatment. (...)
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  7. COVID-19 vaccine boosters for all adults: An optimal U.s. approach?Ameet Sarpatwari, Ankur Pandya, Emily P. Hyle & Govind Persad - 2022 - Annals of Internal Medicine 175 (2):280-282.
    By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the single-dose Johnson & Johnson (...)
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  8. Risk assessment of genetically modified food and neoliberalism: An argument for democratizing the regulatory review protocol of the Food and Drug Administration.Zahra Meghani - 2014 - Journal of Agricultural and Environmental Ethics 27 (6):967–989.
    The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the FDA’s policy (...)
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  9. Chemical Action: What is it and Why Does it Really Matter?W. John Koolage & W. John Koolage & Ralph Hall - 2011 - Journal of Nanoparticle Research 13 (13):1401-1427.
    Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, with (...)
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  10. Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis.Zahra Meghani - 2022 - Globalization and Health 1 (18):1-14.
    In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...)
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  11. Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.Govind Persad, Holly Fernandez Lynch & Patricia J. Zettler - 2021 - Pediatrics 2021:e2021054578.
    We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.
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  12. Arguments for and against Germline Intervention: A Critical Review of Ronald Green’s Babies by Design.Marvin J. H. Lee & Sophia Lozowski - 2017 - Journal of Healthcare Ethics and Administration 3 (1).
    It seems certain that one day we will allow the genetic technology which will enhance our offspring. A highly effective new tool, called CRISPR, which allows for carving out genes, is already being used to edit the genomes of animals. In July 2017, the FDA legalized that germline drugs for therapeutic purposes could be sold in the market. It is a high time, now, that we need engage in discussions about the ethics of germline intervention. To contribute to the discussion (...)
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  13.  91
    Social Value, Beneficial Information, and Obligations to Participants in a Trial of Novel COVID-19 Vaccines.Jake Earl & Liza Dawson - 2023 - American Journal of Bioethics 23 (10):126-128.
    The case describes researchers who are seeking ethics guidance on communicating with participants in a phase-1 COVD-19 vaccine trial about FDA-authorized COVID-19 vaccines (Wilfond, Duenas, and Johnson 2023). The researchers want help choosing among three options they have identified for encouraging participants to obtain one of the authorized vaccines. We argue that research ethics consultants should consider going beyond this question to address another ethics concern the researchers might have overlooked.
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  14. Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación.Carla Saenz, Jackeline Alger, Juan Pablo Beca, José Belizán, María Luisa Cafferata, Julio Arturo Canario Guzman, Jesica Candanedo, Lissette Duque, Lester Figueroa, Ana Garcés, Lionel Gresh, Ida Cristina Gubert, Dirce Guilhem, Gabriela Guz, Gustavo Kaltwasser, Roxana Lescano, Florencia Luna, Alexandrina Cardelli, Ignacio Mastroleo, Irene Melamed, Agueda Muñoz del Carpio Toia, Ricardo Palacios, Gloria Palma, Sofía Salas, Xochitl Sandoval, Sergio Surugi de Siqueira, Hans Vásquez & Bertha Villela de Vega - 2017 - Revista Panamericana de Salud Pública 41 (e13):1-2.
    El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...)
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  15. Between “Research” and “Innovative Therapy”: An Unsettled Moral Dilemma in the Muizelaar Case.Norman Swazo - manuscript
    Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative document is (...)
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  16. Hair Loss Diagnosis and Treatment Expert System.Amal Nabahhin, Alaa Abu Aloun & Suheir H. Almurshidi - 2017 - International Journal of Engineering and Information Systems (IJEAIS) 1 (4):160-169.
    Though hair loss (alopecia) is not a debilitating or life threatening sickness, the very thought of becoming bald can lead to emotional stress and traumatic experience for those who suffer from premature or excessive hair loss. Many will try anything and everything to bring back their locks. Or at least, some of their once full head of hair. Hair loss sufferers spend billions of dollars annually on remedies ranging from drugs, vitamins to special tonics and shampoos. Conventional treatments of hair (...)
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  17. Nutrição e Suplementação Mineral de Bovinos de Corte.Emanuel Isaque Cordeiro da Silva - manuscript
    INTRODUÇÃO -/- A produção bovina no Brasil é fundamentalmente em condições de pastoreio, isto é, à pasto. Dado que as pastagens e as forragens não suprem as exigências minerais dos bovinos, principalmente na seca, a suplementação mineral desses animais torna-se uma prática essencial e obrigatória para obtenção de êxito na produção de carne e leite. Negligenciar os requerimentos minerais dos bovinos pode levar ao aparecimento de alterações metabólicas diretamente relacionadas com o desempenho produtivo do rebanho, além de complicações mínimas ou (...)
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  18. Ovulação Retardada e Anovulação em Vacas: Causas Nutricionais.Emanuel Isaque Cordeiro da Silva - manuscript
    RELAÇÃO E EFEITOS BIOQUÍMICO-NUTRICIONAIS SOBRE A OVULAÇÃO RETARDADA E A ANOVULAÇÃO EM VACAS -/- -/- Emanuel Isaque Cordeiro da Silva -/- Departamento de Agropecuária – IFPE Campus Belo Jardim -/- emanuel.isaque@ufrpe.br ou eics@discente.ifpe.edu.br -/- WhatsApp: (82)98143-8399 -/- -/- 13. OVULAÇÃO RETARDADA -/- A ovulação retardada é uma situação de alteração fisiológica com diferentes origens. A falha em si, ocasiona assincronia nos tempos de liberação dos gametas. O óvulo é liberado tempo depois que os sinais corporais de estro terminaram, dessa forma, (...)
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  19. Ethical Arguments For and Against Sperm Sorting for Non-Medical Sex Selection.Edgar Dahl - 2013 - Reproductive Biomedicine Online 26:231-239.
    Much has been written about the ethics of sex selection. This article thoroughly explores the ethical arguments put forth in the literature both for and against non-medical sex selection using sperm sorting. While most of these arguments come from philosophers, feminist scholars, social scientists and members of the healthcare community, they are often echoed in empirical studies that have explored community values. This review is timely because the first efficacious method for sex selection via sperm sorting, MicroSort, is currently in (...)
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