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# Improve FDA Myelodysplastic Syndromes Guidance
- URL: https://www.fdaweb.com/improve-fda-myelodysplastic-syndromes-guidance/
- Published: 2026-10-21T21:12:21.000Z
- Updated: 2026-10-21T21:12:21.000Z
- Author: David McFarland
- Tags: Drugs

Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in *Blood Advances*, the researchers [say](https://ashpublications.org/bloodadvances/article-pdf/doi/10.1182/bloodadvances.2026022255/2595544/bloodadvances.2026022255.pdf?ref=fdaweb.com) MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could set a precedent that may extend across other rare and heterogeneous malignancies.”

The paper makes recommendations for improving an FDA 7/2025 draft guidance clarifying the agency’s approach to evaluating investigational products for MDS, with a particular focus on improvements in disease classification and trial eligibility, endpoint selection and validation, inclusion of older adults, and safety reporting frameworks.