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 In this section:

        Learn About Drug and Device Approvals

The Drug Development Process

                        
                Step 1: Discovery and Development
          Step 2: Preclinical Research
          Step 3: Clinical Research
          Step 4: FDA Drug Review
          Step 5: FDA Post-Market Drug Safety Monitoring Home
          For Patients
          Learn About Drug and Device Approvals
          The Drug Development ProcessLearn About Drug and Device Approvals The Drug Development Process
  	
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    Print**Step 1**
Discovery and
Development

**Discovery and Development**
Research for a new drug begins in the laboratory.More Information



**Step 2**
Preclinical Research

**Preclinical Research**
Drugs undergo laboratory and animal testing to answer basic questions about safety.More Information



**Step 3**
Clinical Research

**Clinical Research**
Drugs are tested on people to make sure they are safe and effective.More Information



**Step 4**
FDA Review

**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.More Information



**Step 5**
FDA Post-Market
Safety Monitoring

**FDA Post-Market Safety Monitoring**
FDA monitors all drug and device safety once products are available for use by the public.More Information

                                                                                  Content current as of:
      01/04/2018The Drug Development Process                
                          

                        Step 1: Discovery and Development
          Step 2: Preclinical Research
          Step 3: Clinical Research
          Step 4: FDA Drug Review
          Step 5: FDA Post-Market Drug Safety Monitoring
 
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