The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and mitigation strategy (REMS) document for certain high-risk prescription drugs and biologics that pose safety concerns and incorporates “extensive” stakeholder feedback, said the agency.
The draft version of the guidance was first issued for comment in 2017. (RELATED: REMS Format and Content: FDA Offers Draft Guidance, Regulatory Focus 11 October 2017)
The agency said the guidance and a related technical specifications document “are intended to help ensure that REMS documents are clear; understandable to stakeholders; and to the extent possible, consistent in content and format, as well as support submission of REMS document in Structured Product Labeling format, which is required starting December 28, 2022,” said FDA’s announcement…
