Drugs

Hematologic Disorder Drug Development Guidance

FDA has issued a guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals, to assist sponsors in design of nonclinical studies for development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDS). The document says it is intended to streamline development of pharmaceuticals used to treat patients with SDLTHDA, other than cancer, while still protecting patients’ safety and avoiding unnecessary use of animals, in accordance with reduce, refine, replace principles. It applies to pharmaceuticals used both to treat the active disease and to prevent the recurrence of a life-threatening or debilitating event.

The guidance does not address radiopharmaceuticals, vaccines, cellular and gene therapy products, or blood products. It provides recommendations for nonclinical studies in support of trials in patients only.

Contents include Introduction, Background, Nonclinical Evaluations, Timing of Nonclinical Studies, FIH Dose and Dose Escalation, and Other Studies.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome