USA – FDA pilots program to encourage new drug development tools

The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.

The qualification process for DDTs was revamped under the 21st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Animal Rule, which allows for the approval of drugs based on data from animal studies when human efficacy studies are not ethical or feasible.

Under the agency’s new Innovative Science and Technology Approaches for New Drugs (ISTAND) program, FDA says it will offer developers early feedback on proposed DDTs that are “out of scope for existing DDT qualification programs” and provide a path to qualification or other outcomes when qualification is not appropriate…