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FDA’s Role in the Drug Approval Process

This article provides information about the FDA's drug approval process. 

What Does it Mean For a Product to be "FDA-Approved?"

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs, medical devices, food, cosmetics and many other health-related products. In the simplest terms, "FDA approval" means that the FDA has decided the benefits of the approved item outweigh its potential risks.

Before the FDA, companies could make claims about a product, without proof that it was safe or that it even worked. This made consumers extremely vulnerable. Now, new products must go through the FDA approval process before they are available to the public.

Why is the FDA Approval Process Important? 

FDA approval is important, because it validates the need for research on how drugs work on children, not just adults. It also allows us the properly determine the appropriate dosage for children, determine the best route of administration, and test for any drug interactions. 

How Does a Drug or Device Get FDA Approval?

In order to receive FDA approval for a drug or a medical device, the manufacturer must prove to the FDA that the item is "safe and effective." Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.

Here's a brief overview of the steps involved in a drug becoming FDA-approved:

  • Drug Developed: A company develops a new drug and seeks to have it approved by the FDA for sale in the United States.
  • Animal Testing: Before testing the drug on people, the company must test the new drug on animals to find out whether it has the potential to cause serious harm (i.e. toxicity).
  • IND Application: The company submits an Investigational New Drug (IND) application to the FDA based on the results from the initial animal testing. These results must include the drug's composition and manufacturing and the proposed plan for testing the drug on people.
  • Clinical Trials: After the FDA reviews and approves the IND application, clinical trials to test the drug on people can begin. There are 4 phases of clinical trials, starting with small-scale trials, followed by large-scale trials. After the clinical trials, the researchers then submit study reports to the FDA.
  • NDA Application: Once a drug developer provides evidence that the drug is safe and effective, the company can file a New Drug Application (NDA). The FDA reviews the application and makes a decision to approve or not approve the drug.
  • Drug Labeling: The FDA reviews the drug's labeling/packaging and makes sure appropriate information is communicated to health care professionals and consumers.  
  • Facility Inspection: The FDA inspects the facilities where the drug will be manufactured.
  • Drug Approval: The FDA approves the NDA or issues a response letter.
  • Post-Marketing Monitoring: Once the FDA approves the drug, the company is required to submit periodic safety updates to the FDA.

Do Over-the-Counter Drugs and Medical Devices Need FDA Approval?

Yes. Drugs sold over-the-counter (without a prescription) must be approved by the FDA. For instance, over-the-counter pain medications must be FDA-approved to treat pain.

What is Considered When Rescheduling A Drug?

The Controlled Substances Act (CSA), part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal cornerstone of the government’s war against drug abuse. The U.S. Drug Enforcement Administration (DEA) has divided these substances into five categories, called “schedules,” based on each drug’s (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications.. Schedule I is reserved for drugs considered to have the highest potential for abuse and no current accepted medical use. Rescheduling marijuana, for example, would not make it legal but reclassifying the schedule could potentially increase research being done on the drug. Click here to learn more about the FDA's drug approval approcess and marijuana. 

Additional Information:

Last Updated
American Academy of Pediatrics and U.S. Food and Drug Administration (Copyright © 2015)
The information contained on this Web site should not be used as a substitute for the medical care and advice of your pediatrician. There may be variations in treatment that your pediatrician may recommend based on individual facts and circumstances.
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