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PDUFA
The ''Prescription Drug User Fee Act'' (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process. History The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the FDA. All three groups felt that d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 safety of food, drugs, medical devices, and cosmetics. 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 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was use ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Modernization Act
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities. 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 Food and Drug Administration Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton on 21 November 1997, and was fully enacted by 1 April 1999, putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug Act
The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a neurodegenerative disease that results in the progressive loss of motor neurons that control voluntary muscles. ALS is the most comm ..., Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States. Orphan drug designation does not indicate that the therapeutic is either safe and effective or legal to manufacture and market in the United States. That process is handled through other offices in the US Food and Drug Administration. Instead, the designation means only that the sponsor qualifies for certain benefits from the federal government, such as market exclusivity and reduced taxes. In 1982 an informal coalition of supporters and famil ... [...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] |
Opportunistic Infection
An opportunistic infection is an infection caused by pathogens (bacteria, fungi, parasites or viruses) that take advantage of an opportunity not normally available. These opportunities can stem from a variety of sources, such as a weakened immune system (as can occur in acquired immunodeficiency syndrome or when being treated with immunosuppressive drugs, as in cancer treatment), an altered microbiome (such as a disruption in gut microbiota), or breached integumentary barriers (as in penetrating trauma). Many of these pathogens do not necessarily cause disease in a healthy host that has a non-compromised immune system, and can, in some cases, act as commensals until the balance of the immune system is disrupted. Opportunistic infections can also be attributed to pathogens which cause mild illness in healthy individuals but lead to more serious illness when given the opportunity to take advantage of an immunocompromised host. Types of opportunistic infections A wide vari ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
PhRMA
Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, DC. The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients. At the state level, the organization has lobbied to prevent price limits and greater price transparency for drugs. PhRMA has given substantial dark money donations to right-wing advocacy groups such as the American Action Network (which lobbied heavily against the Affordable Care Act), the Koch brothers' Americans for Prosperity and Grover Norquist's Americans for Tax Reform, while rarely providing some donations to centrist or moderately right-leaning groups such as Center Forward. Membership Leadership George A. Scangos, C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Senate Committee On Health, Education, Labor, And Pensions
The United States Senate Committee on Health, Education, Labor and Pensions (HELP) generally considers matters relating to these issues. Its jurisdiction also extends beyond these issues to include several more specific areas, as defined by Senate rules. While currently known as the HELP Committee, the committee was originally founded on January 28, 1869, as the Committee on Education. Its name was changed to the Committee on Education and Labor on February 14, 1870, when petitions relating to labor were transferred to its jurisdiction from the Committee on Naval Affairs. The committee’s jurisdiction at the end of the 19th and early 20th centuries focused largely on issues relating to federal employees’ working conditions and federal education aid. Prominent action considered by the committee in the 1910s and 1920s included the creation of a national minimum wage, the establishments of a Department of Labor, a Department of Education, and a Children’s Bureau. During th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Diseases
A rare disease is any disease that affects a small percentage of the population. In some parts of the world, an orphan disease is a rare disease whose rarity means there is a lack of a market large enough to gain support and resources for discovering treatments for it, except by the government granting economically advantageous conditions to creating and selling such treatments. Orphan drugs are ones so created or sold. Most rare diseases are genetic and thus are present throughout the person's entire life, even if symptoms do not immediately appear. Many rare diseases appear early in life, and about 30% of children with rare diseases will die before reaching their fifth birthdays. With only four diagnosed patients in 27 years, ribose-5-phosphate isomerase deficiency is considered the rarest known genetic disease. No single cut-off number has been agreed upon for which a disease is considered rare. A disease may be considered rare in one part of the world, or in a particular gro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Didanosine
Didanosine (ddI, DDI), sold under the brand name Videx, is a medication used to treat HIV/AIDS. It is used in combination with other medications as part of highly active antiretroviral therapy (HAART). It is of the reverse-transcriptase inhibitor class. Didanosine was first described in 1975 and approved for use in the United States in 1991. Adverse effects The most common adverse events with didanosine are diarrhea, nausea, vomiting, abdominal pain, fever, headache, and rash. Peripheral neuropathy occurred in 21-26% of participants in key didanosine trials. Pancreatitis is rarely observed but has caused occasional fatalities, and has black box warning status. Other reported serious adverse events are retinal changes, optic neuritis and alterations of liver functions. The risk of some of these serious adverse events is increased by drinking alcohol. In February 2010, the United States Food and Drug Administration issued a statement that patients using didanosine (Videx) are at ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Richard Gelb
Richard Lee Gelb (b. June 8 1924, d. April 4 2004) was an American businessman from New York City. He was a consultant and director of various corporations and not-for-profit entities, and from 1960 to his retirement in 1995 was a senior executive at Bristol-Myers Squibb Company. Biography Gelb was born in New York City, graduated from Phillips Andover, Yale University, and Harvard Business School, and lived most of his life in New York’s Upper East Side. He was former director of the New York Life Insurance Company, The New York Times Company, Bessemer Securities Corporation and Federal Reserve Bank of New York. He was Chairman Emeritus since 1995, Chairman from 1976 to 1995, President from 1967 to 1976, Chief Executive Officer from 1972 to 1993 and a Director since 1960, of the healthcare company Bristol-Myers Squibb. Gelb died of cancer in 2004. Philanthropic work Gelb was director emeritus of Lincoln Center for the Performing Arts, former director of the Council on Forei ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bristol-Myers Squibb
The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the largest U.S. corporations. For fiscal 2021, it had a total revenue of $46.4 billion. Bristol Myers Squibb manufactures prescription pharmaceuticals and biologics in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis, and psychiatric disorders. BMS's primary research and development (R&D) sites are located in Lawrence, New Jersey (formerly Squibb, near Princeton), Summit, New Jersey, formerly HQ of Celgene, New Brunswick, New Jersey, Redwood City, California, and Seville in Spain, with other sites in Devens and Cambridge, Massachusetts, East Syracuse, New York, Braine-l'Alleud, Belgium, Tokyo, Japan, Bangalore, India, and Wirral, United Kingdom. BMS previously had an ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Larry Kramer
Laurence David Kramer (June 25, 1935May 27, 2020) was an American playwright, author, film producer, public health advocate, and gay rights activist. He began his career rewriting scripts while working for Columbia Pictures, which led him to London, where he worked with United Artists. There he wrote the screenplay for the film ''Women in Love'' (1969) and received an Academy Award nomination for his work. In 1978, Kramer introduced a controversial and confrontational style in his novel '' Faggots'', which earned mixed reviews and emphatic denunciations from elements within the gay community for Kramer's portrayal of what he characterized as shallow, promiscuous gay relationships in the 1970s. Kramer witnessed the spread of the disease later known as Acquired Immune Deficiency Syndrome (AIDS) among his friends in 1980. He co-founded the Gay Men's Health Crisis (GMHC), which has become the world's largest private organization assisting people living with AIDS. Kramer grew frust ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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