The U.S. Food and Drug Administration released draft guidance clarifying how measurable residual disease (MRD) negativity and complete response rates can support accelerated approval pathways for multiple myeloma therapies. The agency’s papers offer sponsors a blueprint for using MRD as an early efficacy biomarker in registrational strategies. Regulators emphasize assay validation, standardized MRD thresholds, and clinical‑pathway convergence in submissions; the draft guidance is intended to reduce uncertainty around surrogate endpoints and enable faster access for patients. BioCentury and agency summaries note the move follows industry requests for clearer rules on MRD as a primary endpoint. MRD measures tiny amounts of residual cancer cells after treatment using sensitive molecular or flow cytometry assays; the FDA’s guidance stresses cross‑laboratory reproducibility and predefined statistical plans. Companies with myeloma programs and diagnostics developers will likely need early discussions with the FDA to align on assay choice and confirmatory trial designs.