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Encyclopedia > Approved drug

The United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (clinical trials). The drug manufacturer then files a New Drug Application to the FDA, which reviews the application and either approves or rejects it. The Food and Drug Administration (FDA) of the United States is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics, and blood products in the United States. ... Oral medication A medication is a licenced drug taken to cure or reduce symptoms of an illness or medical condition. ... In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a research study. ... This is required before someone can sell an unapproved drug on the market. ...


The U.S. and Canadian systems of new drug approvals are perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment. It takes 12 years on average for an experimental drug to travel from lab to medicine chest. Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.


See also

Patent medicine is the term given to various medical compounds sold under a variety of names and labels, though they were for the most part actually trademarked medicines, not patented. ... A prescribed dietary supplement is intended to supply nutrients (usually vitamins or minerals) that are missing or not consumed in sufficient quantity in a persons diet. ... A home remedy is a treatment or cure for a disease or other ailment that employs certain foods or other common household items. ... Samuel Hahnemann, the father of homeopathy Homeopathy (also spelled homœopathy or homoeopathy) from the Greek words όμοιος, hómoios (similar) and πάθος, páthos (suffering), is a system of alternative medicine. ... Herbology is the art of combining medicinal herbs. ...

External links


  Results from FactBites:
 
Approved drug - Wikipedia, the free encyclopedia (212 words)
If found to be safe by the FDA and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (clinical trials).
The drug manufacturer then files a New Drug Application to the FDA, which reviews the application and either approves or rejects it.
The U.S. and Canadian systems of new drug approvals are perhaps the most rigorous in the world.
  More results at FactBites »


 

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