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FDA published guidance regarding the development of treatments for acute myeloid leukemia.
FDA published guidance on August 17, 2020on the clinical development of treatments of acute myeloid leukemia (AML), including biologics. The guidance discusses development programs and clinical trial designs, “including indications limited to an individual phase of treatment (e.g., maintenance, transplantation preparative regimen, etc.).”
The guidance document discusses different patient populations including pediatric patients, patients with organ impairment, older patients, and pregnant patients. Efficacy endpoints, exploratory trial considerations, and confirmatory trial considerations are addressed. The guidance also addresses regulatory submissions.