Overview
For drugs treating serious conditions with unmet needs, time is of the essence. We help you apply for FDA expedited programs like Fast Track, Breakthrough Therapy, and Priority Review. We craft the medical arguments that demonstrate your drug's potential to significantly improve patient outcomes.
Key Features
Designation request authorship
Unmet medical need justification
Preliminary clinical evidence presentation
Rolling review planning
Our Process
1
Data Assessment
Evaluating if your data meets the high bar for designation.
2
Request Drafting
Writing a focused, data-driven request.
3
Advocacy
Championing your request during agency discussions.
Project Complete & Deliverables Provided
Frequently Asked Questions
Fast Track is for drugs treating serious conditions with unmet medical need—qualification can be based on preclinical data alone. Breakthrough Therapy has a higher bar: you must show preliminary clinical evidence of substantial improvement over existing therapies. Breakthrough gets you everything Fast Track offers, plus intensive FDA guidance, senior manager involvement, and organizational commitment.
Why Choose Us
- More frequent FDA interactions
- Rolling review of the NDA/BLA
- Reduced review clock (6 months vs 10)
- Organizational commitment from FDA
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for Fast Track & Breakthrough Requests.
Schedule ConsultationWhat Our Clients Say
"Our Phase 2 data showed a 40% response rate in a cancer with no approved therapies. Adelphi helped us secure Breakthrough designation, which gave us direct access to FDA reviewers throughout development. We went from Phase 2 to approval in under 3 years."
Dr. James Park
Chief Medical Officer
Oncology Biotech
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