FDA Update – FDA launces new program to support use of Novel Drug Development Tools

The FDA has just launched a new program, the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is meant for developers of novel drug development tools (DDTs), allowing pathways for those developers to submit proposals for novel approaches that are currently without an existing regulatory path.

The existing DDT qualification programs are biomarkers, clinical outcome assessments, and animal models for use of the Animal Rule. ISTAND’s goal is to provide the scientific and logistical support to developers and the FDA’s clinical divisions for incorporation of novel technologies to ultimately accelerate new therapeutics for patients.

Key benefits of the ISTAND program:

• Access to FDA feedback at an early stage of tool development – building developer’s and FDA’s confidence in emerging technologies for first time use under the DDT pathway
• Potential for qualification under the DDT Qualification process, with the flexibility to offer other outcomes if qualification is not the best path
• New platforms to efficiently collaborate and share knowledge of new tools across FDA divisions and with external stakeholders including international regulatory bodies, creating more consensus and consistent views from the agency.

Included on the FDA’s ISTAND webpage, they list submissions that might be considered for ISTAND as well as outcomes that are available under this pilot program. However, since this is a pilot program, the FDA is anticipating that only 2 to 4 applications will be accepted into the ISTAND program each year through a triage and selection process.

You can find the ISTAND Submission Process on the FDA’s website.

For assistance with compliance with the FDA and assistance with submission to the new ISTAND pilot program, please email mdi Consultants at [email protected] RE: ISTAND.