What is Rolling Submission?

Definition

Rolling Submission (or Rolling Review) allows drug sponsors to submit completed sections of an NDA or BLA for FDA review before the entire application is ready. This phased approach enables FDA to begin reviewing available data while sponsors finalize remaining sections.

How Rolling Submission Works

Instead of waiting until all data is compiled, sponsors submit modules as they’re completed. FDA reviews each section, providing a head start on the overall review timeline.

Eligibility

• Fast Track designated products
• Breakthrough Therapy designated products
• RMAT designated products
• Other products with FDA agreement

Typical Submission Order

1. Module 1: Administrative and prescribing information
2. Module 2: Summaries (quality, nonclinical, clinical)
3. Module 3: Quality/CMC documentation
4. Module 4: Nonclinical study reports
5. Module 5: Clinical study reports

Benefits of Rolling Submission

Rolling review provides strategic advantages:

1. Time Savings: 2-6 months accelerated timeline
2. Early Feedback: FDA may identify issues sooner
3. Resource Efficiency: Parallel preparation and review
4. Flexibility: Adjust later sections based on FDA input

Why BD Teams Track Rolling Submissions

For business development professionals, rolling submission signals expedited programs:

• Deal Implication: Products in rolling review are closer to market than submission date suggests
• Due Diligence Focus: Verify Fast Track or Breakthrough status enabling rolling review
• Opportunity Signal: Rolling submission indicates FDA alignment and potentially accelerated timeline to approval