Drug Development Process has five steps
- 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 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.
- Step 5 FDA Post-Market Safety Monitoring: 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.