Biopharmaceutical
Development

  • 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.