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Biologics Control Act
The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States. It was enacted in response to two incidents involving the deaths of 22 children who had contracted tetanus from contaminated vaccines. This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938. Biologics control is now under the supervision of the U.S. Food and Drug Administration (FDA). History When the large scale production of vaccines and anti-toxin serum began in the late 19th century, the United States had no government regulations on biological products. In 1901, a 5-year-old girl died of tetanus in St. Louis, Missouri, after being given a diphtheria anti-toxin. Investigations found that the St. Louis Board of Health produced the contaminated anti-toxin using the blood of a horse infecte ...
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Theodore Roosevelt
Theodore Roosevelt Jr. ( ; October 27, 1858 – January 6, 1919), often referred to as Teddy or by his initials, T. R., was an American politician, statesman, soldier, conservationist, naturalist, historian, and writer who served as the 26th president of the United States from 1901 to 1909. He previously served as the 25th vice president under President William McKinley from March to September 1901 and as the 33rd governor of New York from 1899 to 1900. Assuming the presidency after McKinley's assassination, Roosevelt emerged as a leader of the Republican Party and became a driving force for anti-trust and Progressive policies. A sickly child with debilitating asthma, he overcame his health problems as he grew by embracing a strenuous lifestyle. Roosevelt integrated his exuberant personality and a vast range of interests and achievements into a "cowboy" persona defined by robust masculinity. He was home-schooled and began a lifelong naturalist avocation before attendi ...
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National Institutes Of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1880s and is now part of the United States Department of Health and Human Services. The majority of NIH facilities are located in Bethesda, Maryland, and other nearby suburbs of the Washington metropolitan area, with other primary facilities in the Research Triangle Park in North Carolina and smaller satellite facilities located around the United States. The NIH conducts its own scientific research through the NIH Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program. , the IRP had 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, being the largest biomedical researc ...
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Drug Safety
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an advers ...
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1902 In American Law
Nineteen or 19 may refer to: * 19 (number), the natural number following 18 and preceding 20 * one of the years 19 BC, AD 19, 1919, 2019 Films * ''19'' (film), a 2001 Japanese film * ''Nineteen'' (film), a 1987 science fiction film Music * 19 (band), a Japanese pop music duo Albums * ''19'' (Adele album), 2008 * ''19'', a 2003 album by Alsou * ''19'', a 2006 album by Evan Yo * ''19'', a 2018 album by MHD * ''19'', one half of the double album ''63/19'' by Kool A.D. * '' Number Nineteen'', a 1971 album by American jazz pianist Mal Waldron * ''XIX'' (EP), a 2019 EP by 1the9 Songs * "19" (song), a 1985 song by British musician Paul Hardcastle. * "Nineteen", a song by Bad4Good from the 1992 album ''Refugee'' * "Nineteen", a song by Karma to Burn from the 2001 album ''Almost Heathen''. * "Nineteen" (song), a 2007 song by American singer Billy Ray Cyrus. * "Nineteen", a song by Tegan and Sara from the 2007 album '' The Con''. * "XIX" (song), a 2014 song by Sl ...
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United States Federal Health Legislation
United may refer to: Places * United, Pennsylvania, an unincorporated community * United, West Virginia, an unincorporated community Arts and entertainment Films * ''United'' (2003 film), a Norwegian film * ''United'' (2011 film), a BBC Two film Literature * ''United!'' (novel), a 1973 children's novel by Michael Hardcastle Music * United (band), Japanese thrash metal band formed in 1981 Albums * ''United'' (Commodores album), 1986 * ''United'' (Dream Evil album), 2006 * ''United'' (Marvin Gaye and Tammi Terrell album), 1967 * ''United'' (Marian Gold album), 1996 * ''United'' (Phoenix album), 2000 * ''United'' (Woody Shaw album), 1981 Songs * "United" (Judas Priest song), 1980 * "United" (Prince Ital Joe and Marky Mark song), 1994 * "United" (Robbie Williams song), 2000 * "United", a song by Danish duo Nik & Jay featuring Lisa Rowe Television * ''United'' (TV series), a 1990 BBC Two documentary series * ''United!'', a soap opera that aired on BBC One from 1965 ...
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Vaccination Law
Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating the body's adaptive immunity, they help prevent sickness from an infectious disease. When a sufficiently large percentage of a population has been vaccinated, herd immunity results. Herd immunity protects those who may be immunocompromised and cannot get a vaccine because even a weakened version would harm them. The effectiveness of vaccination has been widely studied and verified. Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the elimination of diseases such as polio and tetanus from much of the world. However, some diseases, such as measles outbreaks in America, have seen rising cases due to relative ...
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57th United States Congress
The 57th United States Congress was a meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives. It met in Washington, DC from March 4, 1901, to March 4, 1903, during the final six months of U.S. President William McKinley's presidency, and the first year and a half of the first administration of his successor, U.S. President Theodore Roosevelt. The apportionment of seats in the House of Representatives was based on the Eleventh Census of the United States in 1890. Both chambers had a Republican majority. Major events * September 6, 1901: Leon Czolgosz shot President William McKinley at the Pan-American Exposition in Buffalo, New York * September 14, 1901: President William McKinley died. Vice President Theodore Roosevelt became President of the United States * October 16, 1901: President Roosevelt invited African American leader Booker T. Washington to the White House. The ...
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Gene Therapy
Gene therapy is a Medicine, medical field which focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material. The first attempt at modifying human DNA was performed in 1980, by Martin Cline, but the first successful nuclear gene transfer in humans, approved by the National Institutes of Health, was performed in May 1989. The first therapeutic use of gene transfer as well as the first direct insertion of human DNA into the nuclear genome was performed by French Anderson in a trial starting in September 1990. It is thought to be able to cure many genetic disorders or treat them over time. Between 1989 and December 2018, over 2,900 clinical trials were conducted, with more than half of them in Phases of clinical research, phase I.
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Xenotransplantation
Xenotransplantation (''xenos-'' from the Greek meaning "foreign" or strange), or heterologous transplant, is the transplantation of living cells, tissues or organs from one species to another. Such cells, tissues or organs are called xenografts or xenotransplants. It is contrasted with allotransplantation (from other individual of same species), syngeneic transplantation or isotransplantation (grafts transplanted between two genetically identical individuals of the same species) and autotransplantation (from one part of the body to another in the same person). Xenotransplantation of human tumor cells into immunocompromised mice is a research technique frequently used in pre-clinical oncology research. Human xenotransplantation offers a potential treatment for end-stage organ failure, a significant health problem in parts of the industrialized world. It also raises many novel medical, legal and ethical issues. A continuing concern is that many animals, such as pigs, have a ...
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Probiotic
Probiotics are live microorganisms promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut microbiota. Probiotics are considered generally safe to consume, but may cause bacteria-host interactions and unwanted side effects in rare cases. There is some evidence that probiotics are beneficial for some conditions, but there is little evidence for many of the health benefits claimed for them. The first discovered probiotic was a certain strain of bacillus in Bulgarian yoghurt, called ''Lactobacillus bulgaricus''. The discovery was made in 1905 by Bulgarian physician and microbiologist Stamen Grigorov. The modern-day theory is generally attributed to Russian Nobel laureate Élie Metchnikoff, who postulated around 1907 that yoghurt-consuming Bulgarian peasants lived longer. A growing probiotics market has led to the need for stricter requirements for scientific substantiation of putative benefits conferred by microorganisms ...
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Center For Biologics Evaluation And Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and cell, tissue, and gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER). Scope * Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- plasma derivatives, including immunoglobulins, hyperimmune products, and antitoxins. ** Blood and blood products activities are managed through the Office of Blood Research and Review (OBRR) * Hu ...
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Ransdell Act
The Ransdell Act (ch. 251, , codified as amended at , , ), reorganized, expanded and redesignated the ''Laboratory of Hygiene'' (created in 1887) as the National Institute of Health. Congress appropriated $750,000 in the bill for construction of facilities and research fellowships. The NIH grew into today's 27-unit National Institutes of Health). The Ransdell Act was sponsored by and named for Joseph E. Ransdell, a United States senator for the state of Louisiana Louisiana , group=pronunciation (French: ''La Louisiane'') is a state in the Deep South and South Central regions of the United States. It is the 20th-smallest by area and the 25th most populous of the 50 U.S. states. Louisiana is bord .... References 1930 in law United States federal health legislation National Institutes of Health {{US-fed-statute-stub ...
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