In busy year for REMS, FDA addresses opioids, patient counseling, and more

This year saw several key developments in risk evaluation and mitigation strategy (REMS) programs as FDA sought to address public health needs. The agency expanded the opioid REMS program to include immediate-release (IR) opioids, provided a framework for counseling patients, and published draft guidance for industry on the format and content of REMS documents.

This year saw several key developments in risk evaluation and mitigation strategy (REMS) programs as FDA sought to address public health needs. The agency expanded the opioid REMS program to include immediate-release (IR) opioids, provided a framework for counseling patients, and published draft guidance for industry on the format and content of REMS documents.