An investigator proposes to study a market approved product sold to treat high blood pressure in individuals over age 12. This study will look at using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator’s most appropriate course of action? A) Submit the research protocol to OHRP for their review
B) Submit the research protocol to the IRB, but do not submit an IND application to the FDA since the drug is already approved and marketed for this indication.
C) Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting research.
D) Submit an Investigational Device Exemption (IDE) application to the FDA.