💊FDA Guidance on Developing Treatment for Myelodysplastic Syndromes
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment." 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, this guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drug and biological products to support an indication of treatment of MDS. This guidance will focus specifically on development of drug and biological products that are considered disease-modifying and, therefore, will not cover products considered supportive only (e.g., erythropoiesis-stimulating agents). Furthermore, the guidance will not address drug development for MDS/myeloproliferative neoplasms, such as chronic myelomonocytic leukemia, which are considered a separate class of myeloid neoplasms.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The guidance announces the FDA's approach to developing drug and biological products for treating myelodysplastic syndromes (MDS), impacting businesses in the pharmaceutical industry regarding compliance with new regulations and clinical trial designs. This could affect their market strategies and R&D investments.