- The Drug Development Process
- Step 1: Discovery and Development Research for a new drug begins in the laboratory.
- Step 2: Preclinical Research Drugs undergo laboratory and 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: PPB Drug Review PPB 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.
- Step 5: PPB Post-Market Drug Safety Monitoring PPB monitors all drug and device safety once products are available for use by the public.