The U.S. Food and Drug Administration (FDA) is expanding the use of real-time review programs, allowing regulators to evaluate portions of an application as data becomes available rather than waiting for a complete submission. As manufacturers look ahead to 2026, these programs are becoming increasingly important for sponsors seeking earlier decisions, greater predictability, and more efficient development timelines.
A Shift in How FDA Reviews Data
Real-time review is designed to speed up regulatory decision-making without lowering standards for safety or effectiveness. Under this model, portions of a submission — such as clinical study data or Chemistry, Manufacturing, and Controls (CMC) information — can be reviewed as soon as they are ready.
This approach has expanded beyond oncology and emergency response products. FDA has now begun using elements of real-time review across a broader range of therapies, reflecting the agency’s efforts to modernize the review process and reduce unnecessary delays.
Why More Sponsors Are Using Real-Time Review
Manufacturers are increasingly pursuing real-time review because it can:
- Shorten overall review timelines
- Reduce last-minute deficiencies
- Improve clarity through ongoing communication with FDA
- Support more efficient resource planning for development teams
For products with strong preliminary data or well-established safety profiles, real-time review can offer a strategic advantage in accelerating the path to market.
Challenges for Smaller or Emerging Sponsors
While real-time review offers clear benefits, it also introduces new pressures for teams preparing submissions. Challenges include:
- Ensuring data packages are ready earlier and in the correct format
- Maintaining consistent quality documentation under tight timelines
- Coordinating multidisciplinary teams to support rolling interactions
- Responding quickly to FDA feedback throughout the review period
Smaller companies or first-time sponsors may find it difficult to meet these expectations without additional regulatory expertise and structured submission planning.
What This Means for 2026 Submissions
As real-time review becomes more common, FDA is signaling an emphasis on:
- Early engagement between sponsors and review teams
- Transparent data packages with clear traceability
- Strong CMC readiness earlier in development
- Robust clinical evidence that can withstand rolling evaluation
Sponsors should expect more opportunities for accelerated review — but only if their development programs are organized, well-documented, and aligned with FDA expectations early in the process.
At EMMA International
EMMA International supports manufacturers preparing for the demands of real-time review and accelerated regulatory pathways. Our team assists with:
- Regulatory strategy and meeting preparation
- Data and documentation readiness
- CMC planning and quality system alignment
- Gap assessments and submission support
As FDA continues to expand real-time review opportunities, EMMA International helps organizations develop efficient, compliant pathways from early development through market authorization.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Food and Drug Administration. (2024). Real-Time Oncology Review (RTOR) and other expedited programs. U.S. Food and Drug Administration. https://www.fda.gov
Food and Drug Administration. (2025). Modernizing review processes: FDA initiatives to enhance regulatory efficiency. U.S. Food and Drug Administration. https://www.fda.gov
Regulatory Affairs Professionals Society. (2025). Trends in accelerated and real-time review programs across FDA centers. Regulatory Focus.
