Antibiotic Development To Advance Patient Treatment
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Antibiotic Development To Advance Patient Treatment
The Antibiotic Development to Advance Patient Treatment (ADAPT) Act () was introduced in the U.S. Congress on December 12, 2013 by Representative Phil Gingrey of Georgia and fifty-two cosponsors. Responding to the lack of financial incentives for drug manufacturers to innovate new antibiotics and antifungals and the regulatory barriers to their doing so, it proposed an expedited pathway for testing drugs intended for diseases for which no cure yet existed. After it died in committee, a similar version of the Act was re-introduced by Representative John Shimkus of Illinois and his cosponsor Representative Gene Green of Texas. Though this Act likewise failed to make it out of committee, several of its provisions were codified in the 21st Century Cures Act, which was signed into law on December 13, 2016. These include the expedited testing pathway for new antibiotics and a similar provision for antimicrobial susceptibility tests. Background Antibiotic resistance and the barriers ...
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United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washington, D.C. Senators and representatives are chosen through direct election, though vacancies in the Senate may be filled by a governor's appointment. Congress has 535 voting members: 100 senators and 435 representatives. The U.S. vice president has a vote in the Senate only when senators are evenly divided. The House of Representatives has six non-voting members. The sitting of a Congress is for a two-year term, at present, beginning every other January. Elections are held every even-numbered year on Election Day. The members of the House of Representatives are elected for the two-year term of a Congress. The Reapportionment Act of 1929 establishes that there be 435 representatives and the Uniform Congressional Redistricting Act requires ...
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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 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 us ...
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Tick-borne Disease
Tick-borne diseases, which afflict humans and other animals, are caused by infectious agents transmitted by tick bites. They are caused by infection with a variety of pathogens, including rickettsia and other types of bacteria, viruses, and protozoa. The economic impact of tick-borne diseases is considered to be substantial in humans, and tick-borne diseases are estimated to affect ~80 % of cattle worldwide. 18 tick-borne pathogens have been identified in the United States according to the Centers for Disease Control and at least 27 are known globally. New tick-borne diseases have been discovered in the 21st century, due in part to the use of molecular assays and next-generation sequencing. The occurrence of ticks and tick-borne illnesses in humans is increasing. Tick populations are spreading into new areas, in part due to climate change. Tick populations are also affected by changes in the populations of their hosts (e.g. deer, cattle, mice, lizards) and those hosts' p ...
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Medicare (United States)
Medicare is a government national health insurance program in the United States, begun in 1965 under the Social Security Administration (SSA) and now administered by the Centers for Medicare and Medicaid Services (CMS). It primarily provides health insurance for Americans aged 65 and older, but also for some younger people with disability status as determined by the SSA, including people with end stage renal disease and amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). In 2018, according to the 2019 Medicare Trustees Report, Medicare provided health insurance for over 59.9 million individuals—more than 52 million people aged 65 and older and about 8 million younger people. According to annual Medicare Trustees reports and research by the government's MedPAC group, Medicare covers about half of healthcare expenses of those enrolled. Enrollees almost always cover most of the remaining costs by taking additional private insurance and/or by joining a public Part C or P ...
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Bipartisanship
Bipartisanship, sometimes referred to as nonpartisanship, is a political situation, usually in the context of a two-party system (especially those of the United States and some other western countries), in which opposing political parties find common ground through compromise. In multi-partisan electoral systems or in situations where multiple parties work together, it is called multipartisanship. Partisanship is the antonym, where an individual or political party adheres only to its interests without compromise. Usage The adjective ''bipartisan'' can refer to any political act in which both of the two major political parties agree about all or many parts of a political choice. Bipartisanship involves trying to find common ground, but there is debate whether the issues needing common ground are peripheral or central ones. Often, compromises are called bipartisan if they reconcile the desires of both parties from an original version of legislation or other proposal. Failure to a ...
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Antimicrobial Stewardship
Antimicrobial stewardship is the systematic effort to educate and persuade prescribers of antimicrobials to follow evidence-based prescribing, in order to stem antimicrobial overuse, and thus antimicrobial resistance. AMS has been an organized effort of specialists in infectious diseases, both in Internal Medicine and Pediatrics with their respective peer-organizations, hospital pharmacists, the public health community and their professional organizations since the late 1990s. It has first been implemented in hospitals. In the U.S., within the context of physicians' prescribing freedom (choice of prescription drugs), AMS had largely been voluntary self-regulation in the form of policies and appeals to adhere to a prescribing self-discipline until 2017, when the Joint Commission prescribed that hospitals should have an Antimicrobial Stewardship team, which was expanded to the outpatient setting in 2020. As of 2019, California and Missouri had made AMS programs mandatory by law. ...
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Medication Package Insert
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly. In the United States, labelling for the healthcare practitioner is called "Prescribing Information" (PI), and labelling for patients and/or caregivers includes "Medication Guides", "Patient Package Inserts", and "Instructions for Use". In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leafl ...
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Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944. The full act is codified in Title 42 of the United States Code (The Public Health and Welfare), Chapter 6A (Public Health Service). Contents The act clearly established the federal government's quarantine authority for the first time. It gave the United States Public Health Service responsibility for preventing the introduction, transmission and spread of communicable diseases from foreign countries into the United States. The Public Health Service Act granted the original authority for scientists and special consultants to be appointed "without regard to the civil-service laws", known as a Title 42 appointment. During COVID-19 pandemic, section has been used for Title 42 expulsion. Amendments It has since been amended many times. Some of these amendments are: *Family Planning Services and Population Research Act of 1970 , which established Title X of the Public Health Service Act, dedicated to pr ...
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Experimental Drug
An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions. In 2018 the United States of America signed the legislation "Right to Try", this allows individuals who fit into the criteria to try experimental drugs that are not yet deemed safe. In the United States, the body responsible for approval is the U.S. Food and Drug Administration (FDA), which must grant the substance Investigational New Drug (IND) status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. A drug that is made from a living organism or its products undergoes the same approval process but is called a ...
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Pneumonia
Pneumonia is an inflammatory condition of the lung primarily affecting the small air sacs known as alveoli. Symptoms typically include some combination of productive or dry cough, chest pain, fever, and difficulty breathing. The severity of the condition is variable. Pneumonia is usually caused by infection with viruses or bacteria, and less commonly by other microorganisms. Identifying the responsible pathogen can be difficult. Diagnosis is often based on symptoms and physical examination. Chest X-rays, blood tests, and culture of the sputum may help confirm the diagnosis. The disease may be classified by where it was acquired, such as community- or hospital-acquired or healthcare-associated pneumonia. Risk factors for pneumonia include cystic fibrosis, chronic obstructive pulmonary disease (COPD), sickle cell disease, asthma, diabetes, heart failure, a history of smoking, a poor ability to cough (such as following a stroke), and a weak immune system. Vaccines to ...
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Henry Waxman
Henry Arnold Waxman (born September 12, 1939) is an American politician who served as a U.S. representative from California from 1975 to 2015. He is a member of the Democratic Party. His district included much of the western part of the city of Los Angeles, as well as West Hollywood, Santa Monica, and Beverly Hills, and was numbered the 24th district from 1975 to 1993, the 29th district from 1993 to 2003, and the 30th district from 2003 to 2013, changing because of redistricting after the 1990, 2000, and 2010 censuses. He now serves as chairman at Waxman Strategies, a D. C.-based communications and lobbying firm, working on health care, environmental, energy, technology, financial services, labor, and telecommunications issues. In addition, he serves as a Regent Lecturer for University of California, Los Angeles, and as an advisor and lecturer at the Johns Hopkins Bloomberg School of Public Health. Waxman was considered to be one of the most influential liberal members of Congr ...
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Frank Pallone
Frank Joseph Pallone Jr. (; born October 30, 1951) is an American lawyer and politician serving as the U.S. representative for , serving since 1988. He is a member of the Democratic Party. The district, numbered as the 3rd district from 1988 to 1993, is in the north-central part of the state and includes New Brunswick, Woodbridge Township, Perth Amboy, Sayreville, Edison, Piscataway and Asbury Park. Pallone is the chair of the House Energy and Commerce Committee. Early life, education, and early political career Pallone is a graduate of Middlebury College, The Fletcher School of Law and Diplomacy at Tufts University, and Rutgers School of Law–Camden. Before being elected to the House, he was a member of the Long Branch city council from 1982 to 1988. Pallone was a member of the New Jersey Senate from the 11th district from 1984 to 1988. In 1983, he defeated incumbent Republican State Senator Brian T. Kennedy 50%-49%. In 1987, he was reelected with 60% of the vote, defeating ...
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