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How are drugs approved for use in the United States?

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The U.S. Food and Drug Administration (FDA) is the federal agency responsible for labeling medications and supplements. However, the approval process is different for prescription and for over-the-counter medications.

Prescription Drugs

The FDA must regulate and approve new prescription drugs before they can be sold to the public. In 2011, the last year for which information is available, the FDA approved 35 new drugs for use by the general public.1 Although this number may seem small, the approval process for drugs is extensive.

The manufacturer or sponsor follows a series of important steps, through animal studies and clinical trials in humans, to ensure that the medication is safe, does what it claims to do, and will provide a health benefit. Testing is performed first in laboratories and on animals to determine that the drug is safe and try to understand how the drug might work in humans.

“Clinical trial” is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use.
Sometimes, multiple trials are completed to measure the effectiveness of a particular medication. Participants in the studies are often followed over a period of time. For comparison purposes, some are given a placebo, an inactive or “dummy” medication, while others are given the actual drug. The NICHD and other institutes of the NIH help conduct and support the research but are not involved in the approval or labeling process.

The clinical trial phase can take years to complete. However, once research has shown that the drug is safe and useful, the FDA typically reviews and either approves or denies an application for a new drug within 6 months.

View a PDF of the FDA drug approval process. (PDF - 2.79 MB)

Over-the-Counter Drugs, Dietary and Herbal Supplements

Over-the-counter drugs and dietary and herbal supplements are not formally approved through the FDA. The active ingredients and labeling of medications and supplements in certain classes (like antacids, for example) are reviewed by the FDA to ensure that acceptable ingredients are used and that they are safe. Drug companies must conform to the requirements in the medication or supplement class, but they do not need formal FDA approval to make and sell over-the-counter medications and supplements.

The label will indicate whether a drug or supplement has been FDA approved. Talk to your health care provider about any medications you are currently taking or are considering taking to ensure that they are safe.

Generic Drugs

A generic drug is a medicine that is contains the same active pharmaceutical ingredient as a name-brand drug but is not sold under a brand name. FDA-approved generic drugs meet the same strict standards for safety, efficacy, and quality as name-brand drugs.2

Consumers usually can buy generic drugs at a much lower price than brand-name drugs. Generic versions are not available for every medicine, and in some cases may not be able to be substituted for a brand name product.

When a pharmaceutical company develops a new drug, it is protected under a patent, usually for 20 years. During this time, no other company is allowed to make or sell it. Once the patent expires, that company or another company can make and test another version of the drug. After testing and FDA approval, the company can sell the drug as a generic.3

Consumers can learn whether a generic drug is FDA-approved by using the drug approval references on the FDA website.


  1. U.S. Food and Drug Administration (Nov. 3, 2011). FDA News Release: FDA: 35 innovative new drugs approved in fiscal year 2011 Retrieved April 29, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm [top]
  2. U.S. Food and Drug Administration (Sep. 19, 2012). Facts about generic drugs. Retrieved August 28, 2013, from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm [top]
  3. U.S. Food and Drug Administration (Aug. 24, 2011). Generic drugs: questions and answers. Retrieved August 28, 2013, from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm [top]

Last Updated Date: 09/27/2013
Last Reviewed Date: 01/21/2014
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