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IPLEDGE
The iPLEDGE program is a program by the Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) for managing the risk of isotretinoin (also known as Accutane), 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 Isotretinoin#Teratogenicity (Birth defects), Teratogenicity of isoretinoin'') 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 program was designed by the Isotretinoin Product Manufacturers Group (IPMG) and its chosen vendor, Covance, under the direction of the FDA and went live ...
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Isotretinoin
Isotretinoin, also known as 13-''cis''-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne. It is also used to prevent certain skin cancers (squamous-cell carcinoma), and in the treatment of other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug. The most common adverse effects are dry lips ( cheilitis), dry and fragile skin, and an increased susceptibility to sunburn. Uncommon and rare side effects include muscle aches and pains (myalgias), and headaches. Isotretinoin is known to cause birth defects due to in-utero exposure because of the molecule's close resemblance to retinoic acid, a natural vitamin A derivative that controls normal embryonic development. It is also associated with psychiatri ...
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Isotretinoin
Isotretinoin, also known as 13-''cis''-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne. It is also used to prevent certain skin cancers (squamous-cell carcinoma), and in the treatment of other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug. The most common adverse effects are dry lips ( cheilitis), dry and fragile skin, and an increased susceptibility to sunburn. Uncommon and rare side effects include muscle aches and pains (myalgias), and headaches. Isotretinoin is known to cause birth defects due to in-utero exposure because of the molecule's close resemblance to retinoic acid, a natural vitamin A derivative that controls normal embryonic development. It is also associated with psychiatri ...
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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), 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 ...
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Acne Vulgaris
Acne, also known as ''acne vulgaris'', is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and possible scarring. It primarily affects skin with a relatively high number of oil glands, including the face, upper part of the chest, and back. The resulting appearance can lead to anxiety, reduced self-esteem, and, in extreme cases, depression or thoughts of suicide. Susceptibility to acne is primarily genetic in 80% of cases. The roles of diet and cigarette smoking in the condition are unclear, and neither cleanliness nor exposure to sunlight appear to play a part. In both sexes, hormones called androgens appear to be part of the underlying mechanism, by causing increased production of sebum. Another common factor is the excessive growth of the bacterium ''Cutibacterium acnes'', which is present on the skin. Treatments for acne are ava ...
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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), 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 directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ...
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Covance
Labcorp Drug Development is a contract research organization (CRO) headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance,https://drugdevelopment.labcorp.com/commitment/about-labcorp-drug-development.html> the company is part of Labcorp, which employs more than 70,000 people worldwide. Labcorp Drug Development claims to provide the world's largest central laboratory network. Labcorp Drug Development has been met by fierce activism from animal rights leaders including Jane Goodall for its animal testing procedures. History Pre-Labcorp Drug Development companies (1968–1996) The origins of Labcorp Drug Development go back to 1968, when Environmental Sciences Corporation – which manufactured equipment related to laboratory animals – opened for business in the basement of a former grocery store in Seattle, Washington. In 1972, it purchased a ...
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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 into ...
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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 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. 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 health, pregnancy, preconception and new motherhood, as well a ...
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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 "work" is any creative material made by a person. A painting, a graphic, a book, a song/lyrics to a song, or a photograph of almost anything are all examples of "works". 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 ...
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Miscarriage
Miscarriage, also known in medical terms as a spontaneous abortion and pregnancy loss, is the death of an embryo or fetus before it is able to survive independently. Miscarriage before 6 weeks of gestation is defined by ESHRE as biochemical loss. Once ultrasound or histological evidence shows that a pregnancy has existed, the used term is clinical miscarriage, which can be ''early'' before 12 weeks and ''late'' between 12-21 weeks. Fetal death after 20 weeks of gestation is also known as a stillbirth. The most common symptom of a miscarriage is vaginal bleeding with or without pain. Sadness, anxiety, and guilt may occur afterwards. Tissue and clot-like material may leave the uterus and pass through and out of the vagina. Recurrent miscarriage (also referred to medically as Recurrent Spontaneous Abortion or RSA) may also be considered a form of infertility. Risk factors for miscarriage include being an older parent, previous miscarriage, exposure to tobacco smoke, obesity, dia ...
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United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ...
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American Academy Of Dermatology
The American Academy of Dermatology (AAD) is a non-profit professional organization of dermatologists in the United States and Canada, based in Rosemont, Illinois, near Chicago. It was founded in 1938 and has more than 20,500 members. The Academy grants fellowships and associate memberships, as well as fellowships for nonresidents of the United States or Canada. Since 1979, the AAD also publishes a monthly medical journal, the ''Journal of the American Academy of Dermatology''. To become a Fellow of the American Academy of Dermatology (FAAD), a physician must be a resident of the United States of America or Canada and certified by the American Board of Dermatology or in dermatology by the Royal College of Physicians and Surgeons of Canada. To become an associate member, a physician must have three years of experience in practice or as a teacher or graduate student of dermatology and must have had training that qualifies for examination by the American Board of Dermatology or the R ...
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