Aaron S. Kesselheim

Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs.

PURPOSE To help ensure that a drug's benefits outweigh its risks, the US Food and Drug Administration may require a Risk Evaluation and Mitigation Strategy (REMS) program with requirements such as laboratory tests or special education. Since physicians are often responsible for REMS testing or education, it is critical...

Communicating Drug Safety and Safe Use Conditions in Risk Evaluation and Mitigation Strategy Materials.