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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  3. Learn About Drug and Device Approvals
  4. The Drug Development Process
  1. Learn About Drug and Device Approvals

The Drug Development Process

 
Discovery and Development
Research for a new drug begins in the laboratory.
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Preclinical Research
Drugs undergo laboratory and animal testing to answer basic questions about safety.
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Clinical Research
Drugs are tested on people to make sure they are safe and effective.
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FDA Review
FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
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FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
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