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35 relations: Adverse Event Reporting System, Antibiotic, ClinicalTrials.gov, Democratic Party (United States), Enantiomer, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration, Food and Drug Administration Amendments Act of 2007, Food and Drug Administration Safety and Innovation Act, Frank Pallone, George W. Bush, Homeland security, Joe Barton, John Dingell, Legislation, Michigan, National Academy of Medicine, New Drug Application, Nonprofit organization, Orphan drug, Orphan Drug Act of 1983, Pediatric Trials Network, Pharmaceutical industry, Pharmacovigilance, Positron emission tomography, Prescription Drug User Fee Act, President of the United States, Priority review, Public Health Service Act, Reagan-Udall Foundation, Short and long titles, Television advertisement, Title 21 of the United States Code, United States House Committee on Energy and Commerce, United States Secretary of Health and Human Services.
Adverse Event Reporting System
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) post-marketing safety surveillance program for all approved drug and therapeutic biologic products.
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Antibiotic
An antibiotic (from ancient Greek αντιβιοτικά, antibiotiká), also called an antibacterial, is a type of antimicrobial drug used in the treatment and prevention of bacterial infections.
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ClinicalTrials.gov
ClinicalTrials.gov is a registry of clinical trials.
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Democratic Party (United States)
The Democratic Party is one of the two major contemporary political parties in the United States, along with the Republican Party (nicknamed the GOP for Grand Old Party).
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Enantiomer
In chemistry, an enantiomer, also known as an optical isomer (and archaically termed antipode or optical antipode), is one of two stereoisomers that are mirror images of each other that are non-superposable (not identical), much as one's left and right hands are the same except for being reversed along one axis (the hands cannot be made to appear identical simply by reorientation).
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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 Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
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Food and Drug Administration
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
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Food and Drug Administration Amendments Act of 2007
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007.
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Food and Drug Administration Safety and Innovation Act
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.
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Frank Pallone
Frank Joseph Pallone Jr. (born October 30, 1951) is the U.S. Representative for, serving since 1988.
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George W. Bush
George Walker Bush (born July 6, 1946) is an American politician who served as the 43rd President of the United States from 2001 to 2009.
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Homeland security
Homeland security is an American umbrella term for "the national effort to ensure a homeland that is safe, secure, and resilient against terrorism and other hazards where American interests, aspirations, and ways of life can thrive to the national effort to prevent terrorist attacks within the United States, reduce the vulnerability of the U.S. to terrorism, and minimize the damage from attacks that do occur".
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Joe Barton
Joe Linus Barton (born September 15, 1949) is a Republican politician representing (map) in the U.S. House of Representatives since 1985, and a member of the Tea Party Caucus.
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John Dingell
John David Dingell Jr. (born July 8, 1926) is an American politician who was a member of the United States House of Representatives from December 13, 1955, until January 3, 2015.
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Legislation
Legislation (or "statutory law") is law which has been promulgated (or "enacted") by a legislature or other governing body or the process of making it.
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Michigan
Michigan is a state in the Great Lakes and Midwestern regions of the United States.
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National Academy of Medicine
The National Academy of Medicine (NAM), formerly called the Institute of Medicine (IoM), is an American nonprofit, non-governmental organization.
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New Drug Application
The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
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Nonprofit organization
A non-profit organization (NPO), also known as a non-business entity or non-profit institution, is dedicated to furthering a particular social cause or advocating for a shared point of view.
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Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
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Orphan Drug Act of 1983
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, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.
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Pediatric Trials Network
The Pediatric Trials Network (PTN) is a consortium of clinical research sites located around the United States that are cooperating in the design and conduct of clinical trials to improve health care for young patients.
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Pharmaceutical industry
The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications.
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Pharmacovigilance
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
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Positron emission tomography
Positron-emission tomography (PET) is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the body as an aid to the diagnosis of disease.
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Prescription Drug User Fee Act
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.
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President of the United States
The President of the United States (POTUS) is the head of state and head of government of the United States of America.
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Priority review
Priority review is a mechanism used by the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease.
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Public Health Service Act
The Public Health Service Act is a United States federal law enacted in 1944.
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Reagan-Udall Foundation
The Reagan-Udall Foundation is a private nonprofit (501c3) organization, created to support the mission of the U.S. Food and Drug Administration (FDA) to help equip FDA staff with the highest caliber, regulatory science and technology in order to enhance the safety and effectiveness of FDA regulated products.
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Short and long titles
The short title is the formal name by which a piece of primary legislation may by law be cited in the United Kingdom and other Westminster-influenced jurisdictions (such as Canada or Australia), as well as the United States and the Philippines.
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Television advertisement
A television advertisement (also called a television commercial, commercial or ad in American English, and known in British English as a TV advert or simply an advert) is a span of television programming produced and paid for by an organization.
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Title 21 of the United States Code
Title 21 of the United States Code governs Food and Drugs in the United States Code (U.S.C.).
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United States House Committee on Energy and Commerce
The Committee on Energy and Commerce is one of the oldest standing committees of the United States House of Representatives.
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United States Secretary of Health and Human Services
The United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services, concerned with health matters.
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Redirects here:
Best Pharmaceuticals for Children Act, FDA Amendments Act, Fdaaa, Food and Drug Administration Amendment Act of 2007.
References
[1] https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007
