Approved drug

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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.

In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's 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.

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.[1]

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  1. ^ Ezekiel J. Emanuel. "The Solution to Drug Prices". 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. ...