Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

The Drug Development Process

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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 and make a decision to approve or not to approve it.

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FDA Post-Market Safety Monitoring

FDA monitors all drug safety once products are available for use by the public.