How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

How to Successfully Respond to an FDA Information Request (IR) — and Sleep Well at Night

At a Glance

• Why IRs Happen: The FDA often requests additional information during NDA/BLA reviews. Staying prepared for these Information Requests (IRs) is key to moving your application forward.
• Common Cold Chain Triggers: In particular, temperature-sensitive products may face IRs on product quality, stability, shipping conditions, and performance qualification data.
• Responding Effectively: Provide exactly what the FDA requests—promptly and thoroughly—to keep the review clock moving without delay.
• Sustainability & Strategy: Emphasizing environmentally responsible cold chain processes and learning from past experiences can bolster your credibility and confidence.
• Value of Expert Support: Partnering with specialized consultancies like Modality Solutions can streamline your IR response, supply robust data, and help you sleep easy knowing regulatory requirements are met.

You’ve submitted a new drug application (NDA) or a biologics license application (BLA) for your new drug candidate. Congratulations! Now the long wait begins. Or not.

The US Food & Drug Administration (FDA) strives to review and act on applications within ten months for standard review or six months for priority review, but that doesn’t mean you won’t hear from them in the interim. In fact, it’s common for the FDA to issue an Information Request (IR) during its review cycle. When that happens, it’s critical that you respond quickly, effectively—and with the confidence that lets you rest easy—so your vaccine or therapeutic stays on track for a timely approval.

How and Why You Might Receive an IR

The FDA issues an IR when application reviewers need additional information or clarification on your NDA or BLA. The review team can issue an IR at any point in the review cycle for any section of your drug or biologic application.

IRs are issued while the application review is in progress, not upon its completion, and the review team considers your IR response during its normal review cycle. The good news is that the overall timeline for your review—your “review clock”—does not stop when the IR goes out. However, because the process keeps moving, you must respond promptly, thoroughly, and strategically to the IR. Although uncommon, if your response is significant enough to be considered a major amendment and received within the last three months of the review cycle, it could push the agency’s action due date out by three months.

For temperature-sensitive vaccines or therapeutics, various cold chain issues can trigger an IR. In Modality Solutions’ experience helping pharmaceutical and biotech companies respond to FDA notifications, the following are among the most common cold chain-related issues:

• Confirmation of the drug product’s quality, stability, and safety after shipment. Temperature-sensitive drugs can encounter temperature, vibration, shock, pressure, and humidity hazards in transit. Increasingly, regulators expect to see data demonstrating that your product maintains its quality throughout these environmental hazards. Transport simulation, like that conducted in Modality Solutions’ Transport Simulation Lab, provides the fastest and most reliable way to supply this data—and helps you sleep at night, knowing you have proof of your product’s reliability in the face of regulatory scrutiny.
• Proper performance qualification (PQ). A complex supply chain for a controlled-temperature drug product requires proof that your cold chain process and packaging will perform robustly in the real world. If an NDA or BLA lacks adequate documentation to demonstrate that the PQ was conducted effectively, an IR is likely. Having complete, validated PQ data not only protects your submission but also provides peace of mind that your supply chain is both compliant and sustainable.

 

The “Good Night’s Sleep” Approach to Responding Successfully

An IR from the FDA can feel stressful, but it doesn’t have to rob you—or your organization—of valuable rest. When it comes to cold chain management, Modality Solutions aligns its expertise with your needs, aiming to deliver more than just data or one-time services. Our philosophy focuses on enabling you to sleep soundly, assured that your processes, reputation, and operations are protected. Below are strategies we recommend for responding to an IR while preserving your peace of mind:

1. Don’t panic. IRs are a common, expected part of the NDA/BLA review process. Recognizing this helps maintain perspective and reduces anxiety.
2. Respond promptly. Unlike a Form 483 (where you must respond within 15 days), an IR doesn’t come with a rigid due date. However, the agency needs the information to continue its review without delay. A prompt, well-prepared response keeps the clock moving—and gives you the reassurance that your filing remains on track.
3. Stay focused. Submit only the requested information. Introducing new, unnecessary details could invite further questions or new IRs.
4. Leverage past insights. Use lessons from previous filings—yours or those of other industry partners. Consult seasoned cold chain specialists who have navigated multiple IRs with regulators. By building your internal capabilities, you ensure long-term sustainability and reduce future compliance headaches, which translates to fewer late-night worries.
5. Don’t forget sustainability. Demonstrating a commitment to environmentally responsible cold chain logistics is increasingly important to regulators. Emphasizing how your packaging and transport methods minimize environmental impact can bolster your credibility and align with corporate sustainability goals—another reason to rest easier, knowing you’re addressing both regulatory and societal expectations.

 

Case in Point: Crafting a Successful IR Response

When a Modality Solutions client received an IR after filing a BLA for its antibody-drug conjugate (ADC), our engineers leveraged their experience with 250+ regulatory interactions to help the company respond—quickly and effectively. The ADC comprised a linker, a toxin, and a monoclonal antibody, but the client had not performed transport simulation testing on the monoclonal antibody separately.

During the FDA review cycle, the agency issued an IR requesting data to support the product’s quality under representative or worst-case shipping conditions. Modality Solutions rapidly designed and executed a transport simulation protocol for the mAb in our Transport Simulation Laboratory. We then provided the comprehensive results needed for the client’s IR response. This thorough, data-driven approach alleviated worries about potential delays, ensuring the review cycle kept moving forward. Ultimately, the client received full approval, allowing them—and their leadership team—to rest easy, knowing their ADC met FDA requirements.

The Importance of Sleeping Well in the Long Run

Every IR response is a chance to build greater confidence in your processes and expertise. By proactively addressing cold chain management issues, you reinforce regulatory compliance while laying the groundwork for more efficient and sustainable operations. For Functional VPs and other leaders tasked with the success of their programs, these collective efforts mean far fewer sleepless nights. Modality Solutions’ approach transcends the mere “mattress” of technical solutions by offering the “good night’s sleep” of true peace of mind—through robust data, effective strategies, and proven sustainability practices.

Ready to Rest Easy on Your FDA Submissions?

Responding quickly and effectively to an IR is vital to keeping your NDA or BLA review on track. Modality Solutions has extensive experience helping pharmaceutical and biotech companies respond successfully to IRs, with exceptional outcomes. By partnering with us, you’ll not only streamline your review process but also gain the confidence that your cold chain logistics are optimized, sustainable, and fully compliant.

Schedule a free consultation to learn how our proven approach and “good night’s sleep” philosophy can help you successfully file your drug product—and keep your peace of mind throughout the process.