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# Myelodysplastic Syndrome Drug Development Guide
- URL: https://www.fdaweb.com/myelodysplastic-syndrome-drug-development-guide/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159443

FDA has published a draft guidance, *Myelodysplastic Syndromes: Development of Drug and Biological Products for Treatment*, to assist sponsors in the clinical development of products to treat the syndromes. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/myelodysplastic-syndromes-developing-drug-and-biological-products-treatment?ref=fdaweb.com) contains the agency’s current thinking about the overall development program and clinical trial designs for the development of drugs to support an indication to treat myelodysplastic syndromes (MDS).

The guidance is specific to the development of drugs that are considered disease-modifying and not drugs that are considered as supportive therapy. It also does not address drug development for MDS/myeloproliferative neoplasm overlap syndromes.

The guidance has an Introduction, Background, Development Program, Regulatory Submissions, Glossary, and Appendices.