A pharmaceutical company has developed a new drug that was tested only on adults. The Federal Drug Administration (FDA) has declared this drug to have potential benefits for ill children. According to the Pediatric Research Equity Act (PREA), what may the pharmaceutical company be required to do?

Conduct pediatric drug studies to determine whether the drug is safe and effective in children. Provide labeling stating that the safety and efficacy of the drug is not established for children. Receive a patent extension for conducting pediatric studies to determine use in children. Survey existing data about the drug to determine potential use in the pediatric population.