The U.S. Food and Drug Administration issued draft guidance allowing measurable residual disease (MRD) negativity and complete response rates to support accelerated approvals in multiple myeloma. The agency’s proposal outlines contexts where MRD, a molecular measure of residual tumor burden, could serve as a surrogate for clinical benefit under accelerated pathways. Regulatory briefs and industry reaction emphasized the potential to shorten development timelines, especially for cell therapies and novel modalities. The guidance includes methodological expectations for MRD assessment and evidence standards. Sponsors, trial designers and diagnostics developers will need to align on MRD assays, validation and statistical plans to leverage the pathway.