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IPLEDGE Program
The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) intended to manage the risk of birth defects caused by isotretinoin, a prescription medication used for the treatment of acne. Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE web site in order to receive, prescribe or dispense isotretinoin. Isotretinoin carries a high risk of causing severe birth defects if taken during pregnancy (''see Teratogenicity of isotretinoin'') and the goals of the iPLEDGE REMS (risk evaluation and mitigation strategy) program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin's serious risks and safe-use conditions. The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time called the Isotretinoin Products Manufacturing Group (IPMG) under the direction of the Food and Drug Administration. The program lau ...
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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). However, 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 ...
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Patient's Rights
Patient rights consist of enforceable duties that healthcare professionals and healthcare business persons owe to patients to provide them with certain services or benefits. When such services or benefits become rights instead of simply privileges, then a patient can expect to receive them and can expect the support of people who enforce organization policies or legal codes to intervene on the patient's behalf if the patient does not receive them. A patient's bill of rights is a list of guarantees for those receiving medical care. It may take the form of a law or a non-binding declaration. Typically a patient's bill of rights guarantees patients information, fair treatment, and autonomy over medical decisions, among other rights. India Under the direction of the Ministry of Health and Family Welfare (MOHFW), India's National Human Rights Commission drafted a Charter of Patients' Rights in 2018. Following a recommendation by the National Council of Clinical Establishments, MOHFW ...
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Pharmaceuticals Policy
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products. Funding of research in the life sciences In many countries, an agency of the national government (in the U.S. the NIH, in the U.K. the MRC, and in India the DST) funds university researchers to study the causes of disease, which in some cases leads to the development of discoveries which can be transferred to pharmaceutical companies and biotechnology companies as a basis for drug development. By setting its budget, its research priorities and making decisions about which researchers to fund, there can be a significant impact on the rate of new drug development and on the disease areas in which new drugs are developed. For example, a major investment by the NIH ...
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March Of Dimes
March of Dimes is a United States nonprofit organization that works to improve the health of mothers and babies. The organization was founded by US President Franklin D. Roosevelt in 1938, as the National Foundation for Infantile Paralysis, to combat polio. The name "March of Dimes" was coined by Eddie Cantor as a pun on the newsreel series ''The March of Time''. After funding Jonas Salk's polio vaccine, the organization expanded its focus to the prevention of birth defects and infant mortality. In 2005, as preterm birth emerged as the leading cause of death for children worldwide, research and prevention of premature birth became the organization's primary focus. Organization March of Dimes improves the health of mothers and babies through five programming areas: medical research, education of pregnant women, community programs, government advocacy, and support of pregnant women and mothers. The organization provides women and families with educational resources on baby heal ...
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CC-BY Icon
A Creative Commons (CC) license is one of several public copyright licenses that enable the free distribution of an otherwise copyrighted "work". A CC license is used when an author wants to give other people the right to share, use, and build upon a work that the author has created. CC provides an author flexibility (for example, they might choose to allow only non-commercial uses of a given work) and protects the people who use or redistribute an author's work from concerns of copyright infringement as long as they abide by the conditions that are specified in the license by which the author distributes the work. There are several types of Creative Commons licenses. Each license differs by several combinations that condition the terms of distribution. They were initially released on December 16, 2002, by Creative Commons, a U.S. non-profit corporation founded in 2001. There have also been five versions of the suite of licenses, numbered 1.0 through 4.0. Released in November ...
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Miscarriage
Miscarriage, also known in medical terms as a spontaneous abortion, is an end to pregnancy resulting in the loss and expulsion of an embryo or fetus from the womb before it can fetal viability, survive independently. Miscarriage before 6 weeks of gestation is defined as biochemical loss by European Society of Human Reproduction and Embryology, ESHRE. Once ultrasound or histological evidence shows that a pregnancy has existed, the term used is clinical miscarriage, which can be "early" (before 12 weeks) or "late" (between 12 and 21 weeks). Spontaneous fetal termination after 20 weeks of gestation is known as a stillbirth. The term ''miscarriage'' is sometimes used to refer to all forms of pregnancy loss and pregnancy with abortive outcomes before 20 weeks of gestation. The most common symptom of a miscarriage is vaginal bleeding, with or without pain. Tissue (biology), Tissue and clot-like material may leave the uterus and pass through and out of the vagina. Risk factors for misc ...
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United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States asserts sovereignty over five Territories of the United States, major island territories and United States Minor Outlying Islands, various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's List of countries and dependencies by area, third-largest land area and List of countries and dependencies by population, third-largest population, exceeding 340 million. Its three Metropolitan statistical areas by population, largest metropolitan areas are New York metropolitan area, New York, Greater Los Angeles, Los Angel ...
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Pro-choice
Abortion-rights movements, also self-styled as pro-choice movements, are movements that advocate for legal access to induced abortion services, including elective abortion. They seek to represent and support women who wish to terminate their pregnancy without fear of legal or social backlash. These movements are in direct opposition to anti-abortion movements. The issue of induced abortion remains divisive in public life, with recurring arguments to liberalize or restrict access to legal abortion services. Some abortion-rights supporters are divided as to the types of abortion services that should be available under different circumstances, including periods in the pregnancy such as late term abortions, in which access may or may not be restricted. Terminology Many of the terms used in the debate are political framing terms used to validate one's stance while invalidating the opposition. For example, the labels pro-choice and pro-life imply endorsement of widely held v ...
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American Medical Association
The American Medical Association (AMA) is an American professional association and lobbying group of physicians and medical students. This medical association was founded in 1847 and is headquartered in Chicago, Illinois. Membership was 271,660 in 2022. The AMA's stated mission is "to promote the art and science of medicine and the betterment of public health." The organization was founded with the goal to raise the standards of medicine in the 19th century primarily through gaining control of education and licensing. In the 20th century, the AMA has frequently lobbied to restrict the supply of physicians, contributing to a doctor shortage in the United States. The organization has also lobbied against allowing physician assistants and other health care providers to perform basic forms of health care. The organization has historically lobbied against various forms of government-run health insurance. The Association also publishes the '' Journal of the American Medical Assoc ...
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Women's Rights
Women's rights are the rights and Entitlement (fair division), entitlements claimed for women and girls worldwide. They formed the basis for the women's rights movement in the 19th century and the feminist movements during the 20th and 21st centuries. In some countries, these rights are institutionalized or supported by law, local custom, and behavior, whereas in others, they are ignored and suppressed. They differ from broader notions of human rights through claims of an inherent historical and traditional bias against the exercise of rights by women and girls, in favor of men and boys.Hosken, Fran P., 'Towards a Definition of Women's Rights' in ''Human Rights Quarterly'', Vol. 3, No. 2. (May 1981), pp. 1–10. Issues commonly associated with notions of women's rights include the right to bodily integrity and autonomy, to be free from sexual violence, to Women's suffrage, vote, to hold public office, to enter into legal contracts, to have equal rights in family law, Right to ...
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Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the 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 and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, 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 directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of disea ...
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Abortion
Abortion is the early termination of a pregnancy by removal or expulsion of an embryo or fetus. Abortions that occur without intervention are known as miscarriages or "spontaneous abortions", and occur in roughly 30–40% of all pregnancies. Deliberate actions to end a pregnancy are called induced abortion, or less frequently "induced miscarriage". The unmodified word ''abortion'' generally refers to induced abortion. Common reasons for having an abortion are birth-timing and limiting family size. Other reasons include maternal health, an inability to afford a child, domestic violence, lack of support, feelings of being too young, wishing to complete an education or advance a career, or not being able or willing to raise a child conceived as a result of rape or incest. When done legally in industrialized societies, induced abortion is one of the safest procedures in medicine. Modern methods use medication or surgery for abortions. The drug mifepristone (aka RU-4 ...
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