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An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government.[1]

In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. Drug companies seeking to sell a drug in the United States must first test it. The company then sends the Center for Drug Evaluation and Research (CDER)[2] evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

In the European Union, it is the European Medicines Agency (EMA) that evaluates medicinal products.

On average, only one in every 5,000 compounds that makes it through lead development to the stage of pre-clinical development becomes an approved drug. Only 10% of all drugs started in human clinical trials become an approved drug.[3][4][5]

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ReferencesEdit

  1. ^ "Development and approval process (Drugs)". US Food and Drug Administration. 13 June 2018. Retrieved 4 May 2019.
  2. ^ Research, Center for Drug Evaluation and. "About the Center for Drug Evaluation and Research". www.fda.gov. Retrieved 2018-01-21.
  3. ^ Ezekiel J. Emanuel (9 September 2015). "The Solution to Drug Prices". The New York Times. On average, only one in every 5,000 compounds that drug companies discover and put through preclinical testing becomes an approved drug. Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval. ...
  4. ^ Wong, Chi Heem; Siah, Kien Wei; Lo, Andrew W (31 January 2018). "Estimation of clinical trial success rates and related parameters". Biostatistics. 20 (2): 273–286. doi:10.1093/biostatistics/kxx069. ISSN 1465-4644.
  5. ^ Lowe, Derek (2 February 2018). "A New Look at Clinical Success Rates". In the Pipeline, American Association for the Advancement of Science. Retrieved 4 May 2019.

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