What should an investigator do when planning to study a marketed product for a new age group?

When an investigator plans to study a marketed product for a new age group, it is essential to submit the research protocol to the Institutional Review Board (IRB) and an Investigational New Drug (IND) application to the Food and Drug Administration (FDA).

Submitting the research protocol to the IRB is a critical step in ensuring that the study meets ethical standards and protects the rights and welfare of participants, particularly since the study will involve a new population that may have different responses to the product. The IRB's review process assesses the risks and benefits associated with the research, ensuring compliance with ethical guidelines.

Additionally, submitting an IND application to the FDA is necessary when there is a plan to conduct clinical research involving an investigational use of a marketed product for a different demographic. The FDA requires this application to ensure that the new study is safe and has scientific validity. This process is crucial for safeguarding participants, as it provides the FDA with the information needed to evaluate whether the study meets the regulatory requirements.

Together, these actions demonstrate a commitment to ethical research practices and regulatory compliance when studying the effects of a marketed product in a new age group.