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Abigail Alliance V. Von Eschenbach
''Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach'', 495 F.3d 695 (D.C. Cir. 2007), ''cert denied'', 552 U.S. 1159 (2008) was resolved in early 2008 when the Supreme Court of the United States declined to hear the appeal. Their refusal left standing the appellate court decision, which said that patients have no right to "a potentially toxic drug with no proven therapeutic benefit." Background Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father, Frank Burroughs, formed an organization, the Abigail Alliance for Better Access to Developmental Drugs and sued the FDA for access to Erbitux. At that time, Erbitux was available experimentally only for patients participating in colon cancer clinical trials. The argument made by the Abigail Alliance in court was that terminal cancer patients have a constitutionally protected right to access to experimental medications before ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Court Of Appeals For The District Of Columbia Circuit
The United States Court of Appeals for the District of Columbia Circuit (in case citations, D.C. Cir.) is one of the thirteen United States Courts of Appeals. It has the smallest geographical jurisdiction of any of the U.S. federal appellate courts, and covers only one district court: the U.S. District Court for the District of Columbia. It meets at the E. Barrett Prettyman United States Courthouse, near Judiciary Square, Washington, D.C. The D.C. Circuit's prominence and prestige among American federal courts is second only to the U.S. Supreme Court because its geographic jurisdiction contains the U.S. Capitol and the headquarters of many of the U.S. federal government's executive departments and government agencies, and therefore it is the main federal appellate court for many issues of American administrative law and constitutional law. Four of the current nine justices on the Supreme Court were previously judges on the D.C. Circuit including Chief Justice John Roberts, a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Erbitux
Cetuximab, sold under the brand name Erbitux, is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion. In July 2009, the U.S. Food and Drug Administration (FDA) approved cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab). This was the first genetic test to guide treatment of cancer. In July 2012, the FDA approved a real time PCR companion diagnostic test for KRAS, the therascreen KRAS test. Medical uses In the US, cetuximab is indicated for treatment of head and neck cancer and colorectal cancer. In the EU, cetuximab is indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer and f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Torts
A tort is a civil wrong that causes a claimant to suffer loss or harm, resulting in legal liability for the person who commits the tortious act. Tort law can be contrasted with criminal law, which deals with criminal wrongs that are punishable by the state. While criminal law aims to punish individuals who commit crimes, tort law aims to compensate individuals who suffer harm as a result of the actions of others. Some wrongful acts, such as assault and battery, can result in both a civil lawsuit and a criminal prosecution in countries where the civil and criminal legal systems are separate. Tort law may also be contrasted with contract law, which provides civil remedies after breach of a duty that arises from a contract. Obligations in both tort and criminal law are more fundamental and are imposed regardless of whether the parties have a contract. While tort law in civil law jurisdictions largely derives from Roman law, common law jurisdictions derive their tort law from cust ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Douglas Ginsburg
Douglas may refer to: People * Douglas (given name) * Douglas (surname) Animals * Douglas (parrot), macaw that starred as the parrot ''Rosalinda'' in Pippi Longstocking *Douglas the camel, a camel in the Confederate Army in the American Civil War Businesses * Douglas Aircraft Company * Douglas (cosmetics), German cosmetics retail chain in Europe * Douglas (motorcycles), British motorcycle manufacturer Peerage and Baronetage * Duke of Douglas * Earl of Douglas, or any holder of the title * Marquess of Douglas, or any holder of the title * Douglas Baronets Peoples * Clan Douglas, a Scottish kindred * Dougla people, West Indians of both African and East Indian heritage Places Australia * Douglas, Queensland, a suburb of Townsville * Douglas, Queensland (Toowoomba Region), a locality * Port Douglas, North Queensland, Australia * Shire of Douglas, in northern Queensland Belize * Douglas, Belize Canada * Douglas, New Brunswick * Douglas Parish, New Brunswick * Dougl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Judith Rogers
Judith Ann Wilson Rogers (born July 27, 1939) is a Senior status, Senior United States federal judge, United States circuit judge of the United States Court of Appeals for the District of Columbia Circuit. Education and career Born in New York City, Rogers received an Bachelor of Arts, Artium Baccalaureus degree from Radcliffe College of Harvard University in 1961, a Bachelor of Laws from Harvard Law School in 1964 and a Master of Laws from the University of Virginia School of Law in 1988. After graduating from law school, she was a law clerk at the Juvenile Court of the District of Columbia from 1964 to 1965. She then worked as an Assistant United States Attorney for the District of Columbia from 1965 to 1968, a staff attorney at San Francisco, California, San Francisco Neighborhood Legal Assistance Foundation from 1968 to 1969, and a trial attorney at the United States Department of Justice Criminal Division from 1969 to 1971. From 1971 to 1972, she was General Counsel for the C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
American Society Of Clinical Oncology
The American Society of Clinical Oncology (ASCO) is a professional organization representing physicians of all oncology sub-specialties who care for people with cancer. Founded in 1964 by Fred Ansfield, Harry Bisel, Herman Freckman, Arnoldus Goudsmit, Robert Talley, William Wilson, and Jane C. Wright, it has nearly 45,000 members worldwide. Physician education ASCO offers educational resources for cancer physicians and other health care professionals of clinical oncology. These include scientific meetings, educational conferences, professional workshops, and special symposia on issues of particular relevance and importance to oncologists and researchers. It also produced the patient information website, Cancer.Net. It publishes numerous journals, books, newsletters, and online and multimedia resources; it publishes the ''Journal of Clinical Oncology The ''Journal of Clinical Oncology'' is a peer-reviewed medical journal published 3 times a month by the Lippincott Williams ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
US Constitution
The Constitution of the United States is the supreme law of the United States of America. It superseded the Articles of Confederation, the nation's first constitution, in 1789. Originally comprising seven articles, it delineates the national frame of government. Its first three articles embody the doctrine of the separation of powers, whereby the federal government is divided into three branches: the legislative, consisting of the bicameral Congress (Article I); the executive, consisting of the president and subordinate officers ( Article II); and the judicial, consisting of the Supreme Court and other federal courts ( Article III). Article IV, Article V, and Article VI embody concepts of federalism, describing the rights and responsibilities of state governments, the states in relationship to the federal government, and the shared process of constitutional amendment. Article VII establishes the procedure subsequently used by the 13 states to ratify it. It is regarde ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
BioTime
Lineage Cell Therapeutics, Inc. is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy for the treatment of dry age-related macular degeneration, which i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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