We received 2,522 manufacturing supplements during the year. Click on charts to view larger versions. To protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for our review, we perform on-site inspections of clinical trial study sites, institutional review boards, sponsors, study monitors and contract research organizations. When obtaining data about the safety and effectiveness of drugs, sponsors rely on human volunteers to take part in clinical studies. Protecting volunteers from research risks is a critical responsibility for us and all involved in clinical trials, including manufacturers, institutional review boards, study sponsors, clinical investigators and their staffs, monitors, contract research organizations, hospitals and other institutions.
Research is reviewed and approved by an institutional review board.
Informed consent is obtained from participants. Ongoing clinical trials are actively monitored. Special attention is given to protecting vulnerable populations, such as children, the mentally impaired or prisoners. We require sponsors to disclose financial interests of clinical investigators who conduct studies for them. This helps identify potential sources of bias in the design, conduct, reporting and analysis of clinical studies.