RareMoon Strategically Positions Fast Track Designation (FTD) as a Foundational Step for Expedited Program

While Fast Track designation can be requested any time after an IND is active, we often prepare our clients for this as their first expedited program designation, with plans to stack additional designations — such as Breakthrough or RMAT — as new data emerges.

RareMoon has helped secure numerous Fast Track Designations (FTDs) for programs across therapeutic areas, including oncology, neurology, and rare genetic disorders.

Fast Track is available for drugs and biologics that treat serious conditions and fill an unmet medical need.

How RareMoon partners in Fast Track Designation efforts:

• Evidence-based presentation of early clinical or nonclinical data to support the potential for benefit over existing therapies.
• Strategic assessment of Fast Track eligibility, including unmet need positioning and development stage considerations
• Preparation of the Fast Track Designation request, including all required elements and justification for serious condition and unmet need.