Phase Iv (Noun)
Meaning
Sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials.
Classification
Nouns denoting acts or actions.
Examples
- The pharmaceutical company was required to conduct a phase IV study to assess the long-term safety of their new medication.
- During phase IV, the manufacturer must continue to collect and analyze data on the drug's performance in a larger and more diverse patient population.
- The FDA mandated a phase IV trial to evaluate the effectiveness of the vaccine in children under the age of 5.
- After the initial approval, the company entered phase IV, which involved monitoring the drug's effects in patients with other underlying health conditions.
- The phase IV study revealed some unexpected side effects of the medication, prompting the manufacturer to update the warning label.