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510(k)
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 safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was 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 influenced by the death of more than 100 patien ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Over-the-Counter Hearing Aid Act Of 2017
The ''Over-the-Counter Hearing Aid Act of 2017'' (OTC Hearing Aid Act) was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional (like an audiologist, otolaryngologist, or audiometrist). Regulations for this new class of hearing aid are expected to be released by the end of 2020. History Hearing loss affects approximately 466 million individuals worldwide and is most concentrated among older adults. Approximately half of adults in the US age 60+ have some degree of hearing loss. Despite hearing loss' impact on communication, social functioning, and economic productivity across the life course, hearing aid uptake is no higher than 50% - even in settings where costs are covered by insurance. Barriers to addressing hearing loss in the U.S. include stigma, financial costs, ... [...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). 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Safe Medical Device Amendments Of 1990
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act. Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments. The H.R. 3095 legislation was passed b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pure Food And Drug Act
The s:Pure Food and Drug Act of 1906, Pure Food and Drug Act of 1906, also known as the Wiley Act and Harvey Washington Wiley, Dr. Wiley's Law, was the first of a series of significant consumer protection laws enacted by the United States Congress, and led to the creation of the Food and Drug Administration (FDA). Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry, US Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the Formulary (pharmacy), National Formulary. In the late 1800s, the quality of food in the US decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, inc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Modernization Act Of 1997
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising. In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol. History Congressman Richard Burr and Senator James M. Jeffords were the chairperson sponsors of the Food and Drug Administration Regulatory Modernization Act of 1997 or FDA Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton William Jefferson Clinton (né Blythe III; born August 19, 1946) is an American politician and lawyer who was the 42nd president of the United States from 1993 to 2001. A member of the Democratic Party (United States), ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bioterrorism
Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or their toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism. Definition Bioterrorism agents are typically found in nature, but could be mutated or altered to increase their ability to cause disease, make them resistant to current medicines, or to increase their ability to be spread into the environment. Biological agents can be spread through the air, water, or in food. Biological agents are attractive to terrorists because they are extremely difficult to detect and do not cause illness for severa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Academy Of Sciences
The National Academy of Sciences (NAS) is a United States nonprofit, NGO, non-governmental organization. NAS is part of the National Academies of Sciences, Engineering, and Medicine, along with the National Academy of Engineering (NAE) and the National Academy of Medicine (NAM). As a national academy, new members of the organization are elected annually by current members, based on their distinguished and continuing achievements in original research. Election to the National Academy is one of the highest honors in the scientific field in the United States. Member of the National Academy of Sciences, Members of the National Academy of Sciences serve ''pro bono'' as "advisers to the nation" on science, engineering, and medicine. The group holds a congressional charter under Title 36 of the United States Code. Congress legislated and President Abraham Lincoln signed an Act of Congress (1863) establishing the National Academy of Sciences as an independent, trusted nongovernmen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Efficacy Study Implementation
Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US law. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.Pharmacy Today. August 2008.FDA aims to remove unapproved drugs from market: Risk-based enforcement program focuses on removing potentially harmful products/ref> The Drug Efficacy Study Implementation (DESI) evaluated over 3,000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending. One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA). See also * Estes Kefauver * Federal ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Charles W
The F/V ''Charles W'', also known as Annie J Larsen, is a historic fishing schooner anchored in Petersburg, Alaska. At the time of its retirement in 2000, it was the oldest fishing vessel in the fishing fleet of Southeast Alaska, and the only known wooden fishing vessel in the entire state still in active service. Launched in 1907, she was first used in the halibut fisheries of Puget Sound and the Bering Sea as the ''Annie J Larsen''. In 1925 she was purchased by the Alaska Glacier Seafood Company, refitted for shrimp trawling, and renamed ''Charles W'' in honor of owner Karl Sifferman's father. The company was one of the pioneers of the local shrimp fishery, a business it began to phase out due to increasing competition in the 1970s. The ''Charles W'' was the last of the company's fleet of ships, which numbered twelve at its height. The boat was acquired in 2002 by the nonprofit Friends of the ''Charles W''. The boat was listed on the National Register of Historic Place ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food Safety
Food safety (or food hygiene) is used as a scientific method/discipline describing handling, food processing, preparation, and food storage, storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health, health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to Food labelling regulations, food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental imp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Congress
The United States Congress is the legislature, legislative branch of the federal government of the United States. It is a Bicameralism, bicameral legislature, including a Lower house, lower body, the United States House of Representatives, U.S. House of Representatives, and an Upper house, upper body, the United States Senate, U.S. Senate. They both meet in the United States Capitol in Washington, D.C. Members of Congress are chosen through direct election, though vacancies in the Senate may be filled by a Governor (United States), governor's appointment. Congress has a total of 535 voting members, a figure which includes 100 United States senators, senators and 435 List of current members of the United States House of Representatives, representatives; the House of Representatives has 6 additional Non-voting members of the United States House of Representatives, non-voting members. The vice president of the United States, as President of the Senate, has a vote in the Senate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
62 Cases Of Jam V
6 (six) is the natural number following 5 and preceding 7. It is a composite number and the smallest perfect number. In mathematics A six-sided polygon is a hexagon, one of the three regular polygons capable of tiling the plane. A hexagon also has 6 edges as well as 6 internal and external angles. 6 is the second smallest composite number. It is also the first number that is the sum of its proper divisors, making it the smallest perfect number. It is also the only perfect number that doesn't have a digital root of 1. 6 is the first unitary perfect number, since it is the sum of its positive proper unitary divisors, without including itself. Only five such numbers are known to exist. 6 is the largest of the four all-Harshad numbers. 6 is the 2nd superior highly composite number, the 2nd colossally abundant number, the 3rd triangular number, the 4th highly composite number, a pronic number, a congruent number, a harmonic divisor number, and a semiprime. 6 is also the fir ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
