Developing Drugs to Treat Acute Myeloid Leukemia
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.
Source: FDA
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
