In a significant update to its regulatory review framework, the U.S. Food and Drug Administration (FDA) published a draft guidance in 2018 titled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” This document builds on the original 2005 guidance and reflects two decades of evolving regulatory standards, including developments under PDUFA and the Biosimilar User Fee Act (BsUFA).
Designed for New Drug Applications (NDAs), Biologics License Applications (BLAs), efficacy supplements, and biosimilar submissions, this guidance lays out expectations for both FDA reviewers and sponsors. The goal is to improve review quality, transparency, consistency, and accelerate patient access to innovative therapies.
At BioBoston Consulting, we help early-stage and established life sciences organizations align with evolving FDA expectations. In this article, we break down what this new FDA draft guidance on GRMPs means for your regulatory strategy—and how to prepare your submission teams accordingly.
Why FDA’s Updated GRMP Guidance Matters
This new FDA draft guidance on GRMPs represents more than a routine update—it is a modernization effort that reflects how the FDA evaluates drugs and biologics today.
Key Objectives of the Guidance:
- Ensure a consistent and efficient review process
- Minimize the number of review cycles needed for approval
- Clarify roles and responsibilities of review staff
- Encourage high-quality application submissions
- Promote proactive communication between sponsors and FDA
These changes are especially impactful for sponsors preparing original NDAs, 351(a) and 351(k) BLAs, or biosimilar biological product applications.
A Brief History: From PDUFA III to Present Day
The concept of Good Review Management Principles (GRMPs) dates back to PDUFA III (2002). In 2005, the FDA published its first guidance on GRMPs to define best practices in regulatory review management.
Fast forward to 2024, and the regulatory landscape has changed dramatically. With the rise of breakthrough therapy designations, risk evaluation and mitigation strategies (REMS), and enhanced review programs for new molecular entities (NMEs), FDA’s updated guidance reflects the need for a more agile, structured, and collaborative review framework.
This newly released draft guidance will replace the original 2005 version once finalized.
The Core Values of GRMPs: What Sponsors Must Know
The FDA underscores that quality, consistency, and accountability remain the pillars of its review framework, even as procedures evolve. These fundamental GRMP values are crucial to ensuring that decisions are informed, timely, and based on scientific rigor.
- Accountability
- The FDA is committed to maintaining a robust, transparent review process.
- Review staff are accountable for applying the GRMP framework.
- Sponsors must submit complete, high-quality applications to support FDA’s efficient review.
- Communication
- Transparent and frequent communication improves predictability and reduces review cycle delays.
- Sponsors benefit from understanding FDA expectations, milestones, and regulatory rationale.
- The FDA gains a better understanding of a product’s benefit-risk profile through clear sponsor communication.
- Consistency
- Consistent application of GRMPs ensures fairness and clarity across all reviews.
- Flexibility may be exercised where justified, based on specific product or clinical context.
What This Means for Sponsors of NDAs, BLAs, and Biosimilars
If your organization is preparing or planning to submit an NDA, BLA, or biosimilar application, this draft guidance sets expectations around both process and behavior. The FDA emphasizes that an effective review is a shared responsibility between the agency and the applicant.
Now is the time for sponsors to:
- Evaluate internal regulatory workflows against GRMP principles.
- Invest in communication planning and submission readiness.
- Ensure submission content is organized, data-driven, and easily navigable for reviewers.
- Engage with experts who understand the nuances of FDA review programs.
BioBoston Consulting: Your Partner for Regulatory Excellence
At BioBoston Consulting, we specialize in helping biopharma and biotech companies prepare high-quality FDA submissions that align with the latest regulatory guidance. Our team of experts can support you in:
✅ Interpreting FDA draft guidance on GRMPs
✅ Implementing efficient regulatory review strategies
✅ Enhancing communication plans for FDA interactions
✅ Preparing submission content that meets GRMP expectations
✅ Navigating NDA, BLA, and biosimilar pathways with confidence
Get Ahead of the Curve – Partner with BioBoston Consulting
Are you preparing an NDA, BLA, or biosimilar application? Now is the time to align your internal review practices with the FDA’s updated Good Review Management Principles (GRMPs). Whether you are an early-stage biotech or an established innovator, BioBoston Consulting can help you submit smarter and achieve faster regulatory milestones.
📞 Contact us today for a customized consultation on how to optimize your submission process in light of the FDA’s evolving expectations.