the Drug Approval Process

The drug approval process is a systematic method to ensure that new medications are safe and effective. It begins with laboratory research and animal testing. If results are promising, clinical trials involving human volunteers are conducted in three phases to assess safety and efficacy. After successful trials, the drug manufacturer submits a detailed application to regulatory authorities, like the FDA in the U.S. These authorities review the data and may require additional studies. If approved, the drug can be marketed. Post-approval monitoring continues to ensure ongoing safety and effectiveness as the drug is used by the public.