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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 ... [...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] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 research ins ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Jim (horse)
"Jim" was the name of a former milk wagon horse, who was used to produce serum containing diphtheria antitoxin (antibodies against diphtheria toxin). Jim produced over of diphtheria antitoxin in his career. History On October 2, 1901, Jim showed signs that he had contracted tetanus and was euthanized. After the death of a girl in St. Louis was traced back to Jim's contaminated serum, it was discovered that serum dated September 30 contained tetanus in its incubation phase. This contamination could have easily been discovered if the serum had been tested prior to its use. Furthermore, samples from September 30 had also been used to fill bottles labeled "August 24," while actual samples from the 24th were shown to be free of contamination. These failures in oversight led to the distribution of antitoxin that caused the death of 12 more children. This incident, and a similar one involving contaminated smallpox vaccine, led to the passage of the Biologics Control Act of 1902, whi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Influenza Vaccine
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. The United States Centers for Disease Control and Prevention (CDC) estimates that vaccination against influenza reduces sickness, medical visits, hospitalizations, and deaths. Immunized workers who do catch the flu return to work half a day sooner on average. Vaccine effectiveness in those over 65 years old remains uncertain due to a lack of high-quality research. Vaccinating children may protect those around them. Vaccines are an effective means to control outbreaks of many diseases. However, vaccines for respiratory viral infections such as flu are still suboptimal and do not offer broad-spectrum protection. Vaccination against influenza began in the 1930s, wit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Informatica
Informatica is an American software development company founded in 1993. It is headquartered in Redwood City, California. Its core products include Enterprise Cloud Data Management and Data Integration. It was co-founded by Gaurav Dhillon and Diaz Nesamoney. Amit Walia is the company's CEO. History On 29 April 1999, its Initial public offering on the NASDAQ stock exchange listed its shares under the stock symbol INFA. On 7 April 2015, Permira and Canada Pension Plan Investment Board announced that a company controlled by the Permira funds and CPPIB would acquire Informatica for approximately US$5.3 billion. On 6 August 2015, the acquisition was completed and Microsoft and Salesforce Ventures invested in the company as part of the deal. The company's stock ceased trading on the NASDAQ under the ticker symbol INFA effective on the same date. On 27 October 2021, Informatica again became publicly traded with the INFA stock symbol, this time listed on the NYSE, opening at $27. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine. VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Blood Transfusion
Blood transfusion is the process of transferring blood products into a person's circulation intravenously. Transfusions are used for various medical conditions to replace lost components of the blood. Early transfusions used whole blood, but modern medical practice commonly uses only components of the blood, such as red blood cells, white blood cells, plasma, clotting factors and platelets. Red blood cells (RBC) contain hemoglobin, and supply the cells of the body with oxygen. White blood cells are not commonly used during transfusion, but they are part of the immune system, and also fight infections. Plasma is the "yellowish" liquid part of blood, which acts as a buffer, and contains proteins and important substances needed for the body's overall health. Platelets are involved in blood clotting, preventing the body from bleeding. Before these components were known, doctors believed that blood was homogeneous. Because of this scientific misunderstanding, many patients died ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Title 21 Of The Code Of Federal Regulations
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: * Chapter I — Food and Drug Administration * Chapter II — Drug Enforcement Administration * Chapter III — Office of National Drug Control Policy Chapter I Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: * 11 — electronic records and electronic signature related * 50 Protection of human subjects in clinical trials * 54 Financial disclosure by clinical investigators * 56 Institutional review boards that oversee clinical trials * 58 Good laboratory practices (GLP) for nonclinical studies The 100 series are regulations pertaining to food: * 101, especially 101.9 — Nutrition facts label related ** (c)(2)(ii) — Requirement to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Surgeon General Of The United States
The surgeon general of the United States is the operational head of the United States Public Health Service Commissioned Corps (PHSCC) and thus the leading spokesperson on matters of public health in the federal government of the United States. The Surgeon General's office and staff are known as the Office of the Surgeon General (OSG), which is housed within the Office of the Assistant Secretary for Health. The U.S. surgeon general is nominated by the president of the United States and confirmed by the Senate. The surgeon general must be appointed from individuals who are members of the regular corps of the U.S. Public Health Service and have specialized training or significant experience in public health programs. However, there is no time requirement for membership in the Public Health Service before holding the office of the Surgeon General, and nominees traditionally were appointed as members of the Public Health Service and as Surgeon General at the same time. The Surgeon ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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