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Executive Order 13139
Executive Order 13139— entitled ''Improving Health Protection of Military Personnel Participating in Particular Military Operations'' — as an executive order (EO) issued by U.S. President Bill Clinton on 30 September 1999. It outlines the conditions under which Investigational New Drug (IND) and off-label pharmaceuticals can be administered to U.S. service members. An “off-label" indication is a use of a drug in a manner (or for a condition) other than that for which they were originally licensed. EO13139 provides the US Secretary of Defense guidance regarding the provision of IND products or products unapproved for their intended use as antidotes to chemical, biological, or radiological weapons; stipulates that the U.S. government will administer products approved by the U.S. Food and Drug Administration only for their intended use; provides the circumstances and controls under which IND products may be used. It also stipulates that to administer an IND product, informed ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Executive Order
In the United States, an executive order is a directive by the president of the United States that manages operations of the federal government. The legal or constitutional basis for executive orders has multiple sources. Article Two of the United States Constitution gives presidents broad executive and enforcement authority to use their discretion to determine how to enforce the law or to otherwise manage the resources and staff of the executive branch. The ability to make such orders is also based on expressed or implied Acts of Congress that delegate to the president some degree of discretionary power (delegated legislation).John Contrubis, '' Executive Orders and Proclamations'', CRS Report for Congress #95-722A, March 9, 1999, Pp. 1-2 The vast majority of executive orders are proposed by federal agencies before being issued by the president. Like both legislative statutes and the regulations promulgated by government agencies, executive orders are subject to judicial r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bill Clinton
William Jefferson Clinton ( né Blythe III; born August 19, 1946) is an American politician who served as the 42nd president of the United States from 1993 to 2001. He previously served as governor of Arkansas from 1979 to 1981 and again from 1983 to 1992, and as attorney general of Arkansas from 1977 to 1979. A member of the Democratic Party, Clinton became known as a New Democrat, as many of his policies reflected a centrist "Third Way" political philosophy. He is the husband of Hillary Clinton, who was a senator from New York from 2001 to 2009, secretary of state from 2009 to 2013 and the Democratic nominee for president in the 2016 presidential election. Clinton was born and raised in Arkansas and attended Georgetown University. He received a Rhodes Scholarship to study at University College, Oxford and later graduated from Yale Law School. He met Hillary Rodham at Yale; they married in 1975. After graduating from law school, Clinton returned to Arkansas ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Off-label Pharmaceutical
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited. Indications and labeling laws An ''indication'' is when a drug is medically appropriate for a given condition; an ''approved indication'' is when a government drug r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Secretary Of Defense
The United States secretary of defense (SecDef) is the head of the United States Department of Defense, the executive department of the U.S. Armed Forces, and is a high ranking member of the federal cabinet. DoDD 5100.1: Enclosure 2: a The secretary of defense's position of command and authority over the military is second only to that of the president of the United States, who is the commander-in-chief. This position corresponds to what is generally known as a defense minister in many other countries. The secretary of defense is appointed by the president with the advice and consent of the Senate, and is by custom a member of the Cabinet and by law a member of the National Security Council. The secretary of defense is a statutory office, and the general provision in provides that "subject to the direction of the President", its occupant has "authority, direction, and control over the Department of Defense". The same statute further designates the secretary as "the princip ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
CBRN Defense
Chemical, biological, radiological and nuclear defence (CBRN defence) are protective measures taken in situations in which chemical warfare, chemical, biological warfare, biological, radiological warfare, radiological or nuclear warfare, nuclear warfare (including terrorism) hazards may be present. CBRN defence consists of CBRN passive protection, contamination avoidance, and Weapon of mass destruction, weapons of mass destruction mitigation. A CBRN incident differs from a hazardous material incident in both scope (i.e., CBRN can be a mass casualty situation) and intent. CBRN incidents are responded to under the assumption that they are intentional and malicious; evidence preservation and perpetrator apprehension are of greater concern than with HAZMAT incidents. A 2011 forecast concluded that worldwide government spending on CBRN defence products and services would reach US$8.38bn that year. Etymology In English language, English the term ''CBRN'' is a replacement for the 19 ... [...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] |
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 an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States District Court For The District Of Columbia
The United States District Court for the District of Columbia (in case citations, D.D.C.) is a federal district court in the District of Columbia. It also occasionally handles (jointly with the United States District Court for the District of Hawaii and the High Court of American Samoa) federal issues that arise in the territory of American Samoa American Samoa ( sm, Amerika Sāmoa, ; also ' or ') is an unincorporated territory of the United States located in the South Pacific Ocean, southeast of the island country of Samoa. Its location is centered on . It is east of the Internationa ..., which has no local federal court or United States territorial court, territorial court.https://www.gao.gov/products/GAO-08-1124T U.S. Government Accountability Office. AMERICAN SAMOA: Issues Associated with Some Federal Court Options. September 18, 2008. Retrieved September 7, 2019. Appeals from the District are taken to the United States Court of Appeals for the District of Columbia C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Air Force
The United States Air Force (USAF) is the air service branch of the United States Armed Forces, and is one of the eight uniformed services of the United States. Originally created on 1 August 1907, as a part of the United States Army Signal Corps, the USAF was established as a separate branch of the United States Armed Forces in 1947 with the enactment of the National Security Act of 1947. It is the second youngest branch of the United States Armed Forces and the fourth in order of precedence. The United States Air Force articulates its core missions as air supremacy, global integrated intelligence, surveillance and reconnaissance, rapid global mobility, global strike, and command and control. The United States Air Force is a military service branch organized within the Department of the Air Force, one of the three military departments of the Department of Defense. The Air Force through the Department of the Air Force is headed by the civilian Secretary of the Air Force ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Anthrax Vaccine
Anthrax vaccines are vaccines to prevent the livestock and human disease anthrax, caused by the bacterium ''Bacillus anthracis''. They have had a prominent place in the history of medicine, from Pasteur's pioneering 19th-century work with cattle (the first effective bacterial vaccine and the second effective vaccine ever) to the controversial late 20th century use of a modern product to protect American troops against the use of anthrax in biological warfare. Human anthrax vaccines were developed by the Soviet Union in the late 1930s and in the US and UK in the 1950s. The current vaccine approved by the U.S. Food and Drug Administration (FDA) was formulated in the 1960s. Currently administered human anthrax vaccines include acellular (USA, UK) and live spore (Russia) varieties. All currently used anthrax vaccines show considerable local and general reactogenicity (erythema, induration, soreness, fever) and serious adverse reactions occur in about 1% of recipients. New third ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Register
The ''Federal Register'' (FR or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices. It is published every weekday, except on federal holidays. The final rules promulgated by a federal agency and published in the ''Federal Register'' are ultimately reorganized by topic or subject matter and codified in the '' Code of Federal Regulations'' (CFR), which is updated annually. The ''Federal Register'' is compiled by the Office of the Federal Register (within the National Archives and Records Administration) and is printed by the Government Publishing Office. There are no copyright restrictions on the ''Federal Register''; as a work of the U.S. government, it is in the public domain. Contents The ''Federal Register'' provides a means for the government to announce to the public changes to government requirements, policies, and guidance. * Proposed new rules and regulat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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