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GUIDANCE DOCUMENT

Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment Draft Guidance for Industry July 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-0649
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The purpose of this guidance is to assist sponsors in the clinical development of drug and biological products for the treatment of the myelodysplastic syndromes (MDS), specifically the development of drugs that are considered disease-modifying, and not drugs that are considered as supportive therapy (e.g., erythropoiesis-stimulating agents). Furthermore, the guidance will not address drug development for MDS/myeloproliferative neoplasm overlap syndromes, such as chronic myelomonocytic leukemia, which are considered a separate class of myeloid neoplasms.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-0649.

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