How the FDA Drug Approval Process Works

Karen Lee Richards Health Guide
  • Most of us who live in chronic pain hope for and anxiously await word of any new medication that might bring us some relief.  Sometimes we read of an exciting new discovery which raises our hopes that pain relief may be just around the corner.  But then years may go by before we hear anything else about it. 

    The fact is, developing a new drug is a very long and extremely expensive process.  A new drug's journey from the laboratory to your pharmacy takes an average of 12 years and costs over $350 million.  There are four basic steps in the process of developing a new medication.

    Step 1: Preclinical Research

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    Time:  About 3 ½ years

    The primary goal of preclinical research is to determine if the drug is reasonably safe for use in humans and if it exhibits enough pharmacological benefit to justify commercial development.  During this stage of development, studies are done using both test tubes and animal subjects. 

    When the preclinical research is completed and the drug is determined to be safe enough to test on humans, the drug's sponsor (usually a pharmaceutical company) submits an Investigational New Drug Application to the FDA.  The FDA has 30 days to review the application before the sponsor begins human clinical trials.  For every 1,000 potential new drugs that begin preclinical testing, only one will make it to the human testing stage. 

    Step 2: Clinical Trials

    Time:  About 6 years

    The clinical trials stage of development is when the new drug is tested on human subjects.  There are three phases of clinical trials:

    • Phase I – takes about one year and uses between 20 and 80 volunteers to evaluate the drug's safety, determine a safe dosage range, and identify side effects.  Volunteers may be healthy and/or patients. 
    • Phase II – takes about two years and uses 100 to 300 volunteers to see if the drug is effective and to further evaluate its safety.
    • Phase III – takes about three years and uses 1,000 to 3,000 volunteers to confirm the drug's effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.

    Once Phase III trials have been successfully completed, the sponsor prepares and submits a New Drug Application to the FDA requesting permission to market the drug in the U.S.  This application, which usually consists of about 100,000 pages, is supposed to tell the drug's whole story, including what happened during the clinical trials, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. 

    Step 3: New Drug Application Review

    Time:  About 2 ½ years

    When a New Drug Application is received, the FDA begins its review process.  During this review period, the FDA has to decide:

    • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
    • Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
    • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

      If the FDA has any concerns about the drug after reviewing the application, they may require that additional testing be done before they will consider approving it.  Once the FDA is satisfied that the proposed new drug is safe and beneficial for patients, the application is approved and doctors can begin prescribing it to patients as soon as it is available in pharmacies. 


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      Step 4: Follow-Up Testing

      Even though a drug is approved and available to patients, the testing doesn't stop.  The FDA requires pharmaceutical companies to do post-marketing studies – also called Phase IV clinical trials – to gather additional information such as long-term effectiveness and risks.  Testing may also be done to compare the drug to other drugs already on the market.  If the post-marketing studies reveal dangers to patients, warnings may be added to the drug's label or the drug may even be pulled off the market. 
      Investigational New Drug Application. U.S. Food and Drug Administration. 3/17/2010.
      New Drug Application. U.S. Food and Drug Administration. 6/07/2010.
      Overview of Clinical Trials. CenterWatch. Retrieved 7/21/2010.
      New Drug Approval Process. Retrieved 7/21/2010.


    Published On: July 21, 2010