What must a sponsor-investigator holding an IND report annually to the FDA?

The correct answer is that a sponsor-investigator holding an Investigational New Drug (IND) application must report an IND report annually to the FDA. This requirement is crucial to ensure the safety and efficacy of the investigational drug being studied. The IND report includes information on the progress of the clinical trial, any new safety information, and changes or amendments to the study protocol.

The annual report helps the FDA monitor ongoing clinical trials and allows the agency to assess any potential risks associated with the investigational product. This regulation is in place to protect the health and safety of subjects participating in clinical research.

While other options might relate to regulatory or research activities, they do not fulfill the specific requirement for annual reporting to the FDA that is stipulated for sponsor-investigators. Therefore, the focus on the IND report is essential for maintaining compliance and ensuring that all relevant data regarding the investigational drug is communicated effectively to the FDA.