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                Information for Consumers and Patients | Drugs

Information for Consumers and Patients | Drugs

                        Overview of our role regulating and approving drugs | Video series
          Educational Resources | Free Drug-Related Publications


                        Find Information about a Drug
          Buying & Using Medicine Safely
          Encuentre información sobre un medicamento
          Frequently Asked Questions on Popular Topics
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          Drugs
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          Information for Consumers and Patients | Drugs
          Approved Drugs: Questions and AnswersInformation for Consumers and Patients | Drugs Approved Drugs: Questions and Answers
  
  	
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    Print**How is a medicine approved by FDA?**

Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends FDA's Center for Drug Evaluation and Research (CDER) the data 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 review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Over-the-counter (OTC) drugs are regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

Watch our new video series to learn more about our role in approving and regulating drugs.

**How can I find out if my medicine is approved by FDA?**

To find out if your drug has been approved by FDA, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling. Drugs@FDA contains most of the drug products approved since 1939.

Related Information

FAQs about the FDA Drug Approval Process
	Everything you always wanted to know about approved medicines (but didn't know where to look)
	From Test Tube to Patient: Protecting America's Health Through Human DrugsResources

Drugs@FDA
	FDA's Drug Review Process

                                                                                  Content current as of:
      11/01/2016Information for Consumers and Patients | Drugs

          
                        Overview of our role regulating and approving drugs | Video series
          Educational Resources | Free Drug-Related Publications


                        Find Information about a Drug
          Buying & Using Medicine Safely
          Encuentre información sobre un medicamento
          Frequently Asked Questions on Popular Topics
          Prescription Drug Advertising
          Tips for Parents
          Tips for Seniors
 
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