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Right-to-try Law
Right-to-try laws are U.S. state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA). Prior to the passage of right to try laws, patients needed FDA approval to use experimental drugs. As of 2018, 41 U.S. states had passed right to try laws. The framers of these laws argue that this allows for individualized treatments that are not permitted under the FDA's current regulatory scheme. The value of these laws was questioned on multiple grounds, including the fact that pharmaceutical manufacturers would have no obligation to provide the therapies being sought. A federal right to try law was passed in May 2018. Since the signing of the bill thousands of patients have been able to use the experimental therapies. According to Scott Gottlieb, who served as commissioner of the FDA ...
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Experimental Drug
An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions. In 2018 the United States of America signed the legislation "Right to Try", this allows individuals who fit into the criteria to try experimental drugs that are not yet deemed safe. In the United States, the body responsible for approval is the U.S. Food and Drug Administration (FDA), which must grant the substance Investigational New Drug (IND) status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. A drug that is made from a living organism or its products undergoes the same approval process but is called ...
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Right To Die
The right to die is a concept based on the opinion that human beings are entitled to end their life or undergo voluntary euthanasia. Possession of this right is often understood that a person with a terminal illness, incurable pain, or without the will to continue living, should be allowed to end their own life, use assisted suicide, or to decline life-prolonging treatment. The question of who, if anyone, may be empowered to make this decision is often subject of debate. Religious views on suicide vary from the Hindu and Jain practices of non-violent suicide through fasting ( Prayopavesa and '' Santhara'', respectively) to considering it a grave sin, as in Catholicism. Ethics The preservation and value of life have led to many medical advancements when it comes to treating patients. New devices and the development of palliative care have allowed humans to live longer than before. Prior to these medical advancements and care, the lifespans of those who were unconscious, minim ...
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Peter Temin
Peter Temin (; born 17 December 1937) is an economist and economic historian, currently Gray Professor Emeritus of Economics, MIT and former head of the Economics Department. Education Temin graduated from Swarthmore College in 1959 before earning his Ph.D. at MIT in 1964. Beginning in the 1960s and early 1970s he published on American economic history in the 19th century, including ''The Jacksonian Economy'' (1969) and ''Causal Factors in American Economic Growth in the Nineteenth Century'' (1975), as well as ''Reckoning with Slavery'' (1976), which was an examination of the slave economy and its effects. His papers of the 1960s would reflect intense empirical study as part of his working method, including composition of iron and steel products, which would later be part of his analysis of industrial development. He continued his study of 19th century industrialization with ''Engines of Enterprise''. Influence Two of Temin's most cited conclusions in this area are on the relati ...
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Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning ...
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Alison Bateman-House
Alison may refer to: People * Alison (given name), including a list of people with the name * Alison (surname) Music * ''Alison'' (album), aka ''Excuse Me'', a 1975 album by Australian singer Alison MacCallum * "Alison" (song), song by Elvis Costello * " Alison (C'est ma copine Ă  moi)", a 1993 single by Jordy * "Alison", 1994 single by Slowdive Places * Alison, New South Wales, suburb of the Central Coast region in NSW, Australia * Alison Sound, an inlet on the Central Coast of British Columbia, Canada * Point Alison, Alberta, a summer village in Alberta, Canada Other uses * ''Alison'' (film), a South African documentary film * ALISON (company), an educational technology company * Alison, common name for plants of the genus ''Alyssum'', including: ** Sweet alison, a decorative plant * ''Alison'' (katydid) a genus in the Hexacentrinae subfamily of bush crickets See also * Alisoun (other) * Alisson (other) * Allison (other) * Allisson (di ...
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Rebecca Dresser
Rebecca S. Dresser (born 5 April 1952) is an American legal scholar and medical ethicist. Dresser earned a bachelor of arts degree in psychology and sociology at Indiana University Bloomington in 1973, followed by a master's of science in education at the same institution in 1975. She then graduated from Harvard Law School in 1979. She began teaching at the Washington University in St. Louis Washington University in St. Louis (WashU or WUSTL) is a private research university with its main campus in St. Louis County, and Clayton, Missouri. Founded in 1853, the university is named after George Washington. Washington University is r ... in 1983, was appointed Daniel Noyes Kirby Professor of Law, and granted emeritus status upon retirement. Between 1992 and 1993, Dresser returned to Harvard as faculty fellow of the Safra Center for Ethics. She was diagnosed with cancer of the head and neck in 2006. Selected publications * * * * References {{DEFAULTSORT:Dresser, Rebecca Am ...
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Alta Charo
Robin Alta Charo (born 1958) is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin–Madison and a leading American authority on bioethics. She holds appointments in both Wisconsin's law school and medical school. Charo is among the leading advocates for embryonic stem cell research in the United States. She earned a B.A. in biology from Harvard University in 1979 and a J.D. from Columbia University in 1982. She is a fellow of the Hastings Center, an independent bioethics research institution. In 2020, the American Academy of Arts and Sciences The American Academy of Arts and Sciences (abbreviation: AAA&S) is one of the oldest learned societies in the United States. It was founded in 1780 during the American Revolution by John Adams, John Hancock, James Bowdoin, Andrew Oliver, a ... elected her fellow. References External links Faculty page* Bioethicists Living people 1958 births Harvard College alumni Columbia Law School al ...
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Arthur Caplan
Arthur L. Caplan (born 1950) is the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at New York University Grossman School of Medicine and the founding director of the Division of Medical Ethics. Caplan has made many contributions to public policy including: helping to found the National Marrow Donor Program; creating the policy of required request in cadaver organ donation adopted throughout the United States; helping to create the system for distributing organs in the U.S.; and advising on the content of the National Organ Transplant Act of 1984, rules governing living organ donation, and legislation and regulation in many other areas of health care including blood safety and compassionate use. During the COVID-19 pandemic, he repeatedly stepped into controversy by universally criticizing those who were not fully vaccinated. Referring to them in a CNN appearance, he asserted, "I'll condemn them. I'll shame them. I'm blame them ... We can penalize them more, ...
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Bioethics
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ( "the ethics of the ordinary"), ethical education in science, animal, and environmental ethics, and public health. Etymology The term ''Bioethics'' (Greek , life; , behavior) was coined in 1927 by Fritz Jahr in an article about ...
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Neuroendocrine Tumor
Neuroendocrine tumors (NETs) are neoplasms that arise from cells of the endocrine ( hormonal) and nervous systems. They most commonly occur in the intestine, where they are often called carcinoid tumors, but they are also found in the pancreas, lung, and the rest of the body. Although there are many kinds of NETs, they are treated as a group of tissue because the cells of these neoplasms share common features, such as looking similar, having special secretory granules, and often producing biogenic amines and polypeptide hormones. Classification WHO The World Health Organization (WHO) classification scheme places neuroendocrine tumors into three main categories, which emphasize the tumor grade rather than the anatomical origin: * well-differentiated neuroendocrine tumours, further subdivided into tumors with benign and those with uncertain behavior * well-differentiated (low grade) neuroendocrine carcinomas with low-grade malignant behavior * poorly differentiated (high grad ...
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Expanded Access
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access. In general the person and their doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit. In some countries the government will pay for the drug or ...
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Advanced Accelerator Applications
Advanced Accelerator Applications (AAA or Adacap) is a France-based pharmaceutical group, specialized in the field of nuclear medicine. The group operates in all three segments of nuclear medicine (PET, SPECT and therapy) to diagnose and treat serious conditions in the fields of oncology, neurology, cardiology, infectious and inflammatory diseases. In late October 2017, ''Reuters'' announced that Novartis would acquire the company for $3.9 billion, paying $41 per ordinary share and $82 per American depositary share representing a 47 percent premium. On January 22, 2018, Novartis AG announced the successful completion of the tender offer by its subsidiary, Novartis Groupe France S.A. History AAA was created in 2002 by Italian physicist Stefano Buono to exploit a patent from the European Organization for Nuclear Research (CERN).
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