The Drug Development Process

The Drug Development Process

Step 1: Discovery & Development

Research for a new drug begins in the laboratory.

Step 2: Preclinical ResearchT

Drugs undergo laboratory & animal testing to answer basic questions about safety.

Step 3: Clinical Research

Drugs are tested on people to make sure they are safe and effective.

Step 4: FDA Review

FDA review teams thoroughly examine all of the submitted data related to the drug or device & make a decision to approve or not to approve it.

Step 5: FDA Post-Market Safety Monitoring

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

Step 1: Discovery & Development

Step 2: Preclinical Research

Step 3: Clinical Research

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