Food And Drug Administration Revitalization Act
The Food and Drug Administration Revitalization Act was introduced by the 101st Congress of the United States. Senator Orrin G. Hatch was the chairperson sponsor of the federal revitalization amendment for the Food and Drug Administration. The FDA revitalization was orchestrated by Commissioner of Food and Drugs Dr. David Kessler in pursuant of the congressional authorization permissible by 101st Senate bill 845; Elements of Food and Drug Administration Revitalization * Digital transformation and Information technology harmonizing FDA as information agency *Enforcement programs streamlined by contingencies of FDA field activities *Establishment of Office of Criminal Investigations *New drug approval process funding by prescription drug user fee *Progressive domestic and imports investigation programs by FDA *Proposed rule for regulation of tobacco by U.S. FDA *Quality standards for mammography facilities endorsed by Mammography Quality Act *Reduction in application, IND, ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety, safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford (chemist), Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influe ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Mammography Quality Standards Act
The Mammography Quality Standards Act (MQSA) was enacted by the United States Congress to regulate the quality of care in mammography. The act was officially effective in 1994, and was extended in 2004 to continue through 2007. The U.S. Food and Drug Administration (FDA) began inspections of mammography facilities to ensure compliance in 1995. In 1997, more comprehensive regulation was added to become effective in 1999. The FDA explains MQSA: The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options leading to an increased chance of survival. Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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101st United States Congress
The 101st 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, D.C., from January 3, 1989, to January 3, 1991, during the final weeks of Ronald Reagan's presidency and the first two years of George H. W. Bush's presidency. The apportionment of seats in this House of Representatives was based on the 1980 United States census. Both chambers maintained a Democratic majority. Major events * January 20, 1989: George H. W. Bush became President of the United States * February 9, 1989: President Bush addressed a joint session of Congress * February 23, 1989: Senate Armed Services Committee rejected President Bush's nomination of John Tower for Secretary of Defense * March 24, 1989: Exxon Valdez oil spill * December 20, 1989: Operation Just Cause launched to overthrow Panamanian leader Manuel Noriega Major legislat ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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November 1990 In The United States
November is the eleventh and penultimate month of the year in the Julian and Gregorian calendars. Its length is 30 days. November was the ninth month of the calendar of Romulus . November retained its name (from the Latin ''novem'' meaning "nine") when January and February were added to the Roman calendar. November is a month of late spring in the Southern Hemisphere and late autumn in the Northern Hemisphere. Therefore, November in the Southern Hemisphere is the seasonal equivalent of May in the Northern Hemisphere and vice versa. In Ancient Rome, Ludi Plebeii was held from November 4–17, Epulum Jovis was held on November 13 and Brumalia celebrations began on November 24. These dates do not correspond to the modern Gregorian calendar. November was referred to as Blōtmōnaþ by the Anglo-Saxons. Brumaire and Frimaire were the months on which November fell in the French Republican calendar. Astronomy November meteor showers include the Andromedids, which occurs from Se ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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1990 In American Law
Year 199 ( CXCIX) was a common year starting on Monday of the Julian calendar. At the time, it was sometimes known as year 952 ''Ab urbe condita''. The denomination 199 for this year has been used since the early medieval period, when the Anno Domini calendar era became the prevalent method in Europe for naming years. Events By place Roman Empire * Mesopotamia is partitioned into two Roman provinces divided by the Euphrates, Mesopotamia and Osroene. * Emperor Septimius Severus lays siege to the city-state Hatra in Central-Mesopotamia, but fails to capture the city despite breaching the walls. * Two new legions, I Parthica and III Parthica, are formed as a permanent garrison. China * Battle of Yijing: Chinese warlord Yuan Shao defeats Gongsun Zan. Korea * Geodeung succeeds Suro of Geumgwan Gaya, as king of the Korean kingdom of Gaya (traditional date). By topic Religion * Pope Zephyrinus succeeds Pope Victor I, as the 15th pope. Births Valerian Roman ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Congress
A congress is a formal meeting of the representatives of different countries, constituent states, organizations, trade unions, political parties, or other groups. The term originated in Late Middle English to denote an encounter (meeting of adversaries) during battle, from the Latin '' congressus''. Political congresses International relations The following congresses were formal meetings of representatives of different nations: *The Congress of Aix-la-Chapelle (1668), which ended the War of Devolution *The Congress of Aix-la-Chapelle (1748), which ended the War of the Austrian Succession *The Congress of Aix-la-Chapelle (1818) *The Congress of Berlin (1878), which settled the Eastern Question after the Russo-Turkish War (1877–1878) *The Congress of Gniezno (1000) *The Congress of Laibach (1821) *The Congress of Panama, an 1826 meeting organized by Simón Bolívar *The Congress of Paris (1856), which ended the Crimean War *The Congress of Troppau (1820) *The Congr ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Freedom Of Information Act (United States)
The Freedom of Information Act (FOIA ), , is the United States federal Freedom of information in the United States, freedom of information law that requires the full or partial disclosure of previously unreleased or uncirculated information and documents controlled by the U.S. government upon request. The act defines agency records subject to disclosure, outlines mandatory disclosure procedures, and includes nine exemptions that define categories of information not subject to disclosure. The act was intended to make U.S. government agencies' functions more transparent so that the American public could more easily identify problems in government functioning and put pressure on United States Congress, Congress, agency officials, and the President of the United States, president to address them. The FOIA has been changed repeatedly by both the legislative and executive branches. The FOIA is commonly known for being invoked by News agency, news organizations for reporting purposes ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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General Services Administration
The General Services Administration (GSA) is an Independent agencies of the United States government, independent agency of the United States government established in 1949 to help manage and support the basic functioning of federal agencies. GSA supplies products and communications for U.S. government offices, provides transportation and office space to federal employees, and develops government-wide cost-minimizing policies and other management tasks. GSA employs about 12,000 federal workers. It has an annual operating budget of roughly $33 billion and oversees $66 billion of procurement annually. It contributes to the management of about $500 billion in U.S. federal property, divided chiefly among 8,397 owned and leased buildings (with a total of 363 million square feet of space) as well as a 215,000-vehicle fleet vehicle, motor pool. Among the real estate assets it manages are the Ronald Reagan Building, Ronald Reagan Building and International Trade Center in Washingto ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Nutrition Labeling And Education Act Of 1990
The Nutrition Labeling and Education Act (NLEA) (Public Law 101-535) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush. The law gives the Food and Drug Administration (FDA) authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (for example, 'high fiber', 'low fat', etc.) and health claims meet FDA regulations. The act did not require restaurants to comply with the same standards. The regulations became effective for health claims, ingredient declarations, and percent juice labeling on May 8, 1993 (but percent juice labeling was exempted until May 8, 1994). Effective Jan. 1, 2006, the Nutrition Facts Labels on packaged food products are required by the FDA to list how many grams of trans fatty acid (trans fat) are contained within one serving of the product. Dietary Supplement Act of 1992 Senator Orrin Hatch of Utah introduced the Health Freedom ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Nutrition Facts Label
The nutrition facts label (also known as the nutrition information panel, and other slight variations) is a label required on most convenience food, packaged food in many countries, showing what nutrients and other ingredients (to limit and get enough of) are in the food. Labels are usually based on official nutritional rating systems. Most countries also release overall List of nutrition guides, nutrition guides for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods. Nutrition facts labels are one of many types of food labels required by regulation or applied by manufacturers. They were first introduced in the U.S. in 1994, and in the U.K. in 1996. Australia and New Zealand Australia and New Zealand use a nutritional information panel of the following format: Other items are included as appropriate, and the units may be varied as appropriate (e.g. substituting ml for g, or mmo ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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MedWatch
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also distributes information on medical recalls and other clinical safety communications via its platforms. History MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
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Adverse Event
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs, or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |