FDA Fast Track & Breakthrough Therapy Designation Services

Get assistance navigating the FDA’s most impactful expedited programs with Only Orphans Cote.

Trusted Authority in FDA & EMA Orphan Drug Designation

95% First-Attempt FDA Application Success Rate

Expert Guidance from the Former FDA Director of Orphan Products

Comprehensive Expedited Program Support

Only Orphans Cote helps biotechs secure critical designations like Fast Track and Breakthrough Therapy, both designed to speed development and review of promising drugs. We guide sponsors from eligibility assessment through submission and FDA interactions, ensuring your program is positioned for success.


Only Orphans Cote helps biotechs secure critical designations like Fast Track Designation and Breakthrough Therapy Designation, both designed to speed development and review of promising drugs. We support sponsors from eligibility assessment through submission and FDA interactions, ensuring your program is positioned for success.

Fast Track Designation


What is Fast Track Designation?

Fast Track is an FDA program to speed development and review of drugs for serious conditions with potential to address unmet medical needs. It can be granted based on early data such as nonclinical or preliminary clinical results.


Fast Track Designation Benefits

Benefits include more frequent FDA interactions and eligibility for rolling review, allowing sponsors to submit completed sections of a BLA or NDA before the full application is ready. The goal is to facilitate earlier patient access to promising therapies.


Fast Track Requirements:

  • An open IND
  • Basis for treating a serious condition.
  • Evidence that drug has potential to address unmet medical need (mechanistic rationale, nonclinical data, or preliminary clinical data depending on stage).
Orphan drug consultant and physician sitting together

Breakthrough Therapy Designation


What is Breakthrough Therapy Designation?

Breakthrough Therapy designation is for drugs treating serious conditions where preliminary clinical evidence shows substantial improvement over available therapies on clinically significant endpoints. Unlike Fast Track, it requires actual patient data, typically from early-phase trials.


Breakthrough Therapy Designation Benefits

Benefits include intensive FDA guidance, involvement of senior reviewers, cross-disciplinary support, and eligibility for rolling review. This designation aims to streamline development so that transformative therapies with strong early results can reach patients as efficiently as possible.


Breakthrough Designation Requirements

  • Basis for treating a serious condition.
  • Preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
  • IND documents and submission dates.
Breakthrough Therapy Designation Benefits

Ready to Pursue Fast Track or Breakthrough Therapy Designation?

We offer a free initial consultation to assess your program’s eligibility for FDA Fast Track or Breakthrough Therapy designation. Our experts will review your IND and early data to determine readiness, then design the most effective strategy to help your therapy advance faster.