Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product’s approval process. To succeed, it’s important to follow best practices that focus on clarity, accuracy, and efficient project management.

A key component to success is leveraging a dedicated regulatory planner to streamline efforts, improve team coordination, and ensure timely responses. Here are some best practices to follow for managing FDA information requests.

Leverage a Dedicated Regulatory Planner

A dedicated regulatory planner is essential for effectively managing information requests from the FDA. This individual can prioritize requests, coordinate team efforts, and track progress, allowing subject matter experts (SMEs) to focus on delivering strategic answers. The regulatory planner plays a pivotal role in assigning tasks, determining sources, and managing timelines.

Key Responsibilities:

• Prioritizing Questions: The regulatory planner ensures that high-priority questions are addressed first, coordinating between departments to assign the right resources, whether that’s medical writing support, clinical data expertise, or manufacturing input.
• Coordinating Teams: They facilitate collaboration across teams to determine which experts should handle each request.
• Tracking Progress: The planner uses real-time tracking systems to monitor progress on tasks, ensuring transparency and communication across teams.

Overall Kickoff Meeting (KOM) and Regular Check-ins (Checkpoints)

An overall kickoff meeting should be conducted when the first batch of questions is received from the health authority. This meeting establishes expectations and ways of working, assigns responsibilities, and sets timelines. Following the initial KOM, the regulatory planner leads daily or regular check-ins to monitor progress on those questions, as well as integrate any new batches of questions that come in during the interim.

Key Tip:

The regulatory planner should use these regular check-ins to ensure that timelines remain intact, authors are on track and haven’t encountered any roadblocks, and any adjustments due to new information requests are handled swiftly without derailing progress on earlier tasks.

Prioritize Accuracy and Completeness

Accuracy and completeness are essential when responding to FDA information requests. The regulatory planner ensures that all responses are fully vetted by the necessary experts and quality control (QC) is conducted before submission. This ensures consistency and prevents any issues that could lead to delays or follow-up requests.

Key Tip:

A structured review process should involve cross-functional teams, including clinical, regulatory, and medical writing, to verify that all data provided are accurate and aligned with previous submissions.

Maintain Transparency and Compliance

Transparency in communications with the FDA is critical to building trust and demonstrating compliance. The regulatory planner ensures that all team members have access to previous submissions, allowing them to respond in a manner consistent with the company’s overall regulatory strategy.

Key Tip:

Maintain a centralized document repository where all requests, responses, and supporting documentation are stored. This allows for easy reference and ensures transparency in communications.

Implement Project Management Tools

Project management tools are essential for managing the numerous moving parts involved in responding to FDA requests, most of which need to happen in rapid sequence and in short order. The regulatory planner uses these tools to track deadlines, assign tasks, and monitor progress, ensuring that the entire process remains on schedule.

Key Tip:

Utilize real-time tracking tools like SharePoint or project management platforms to centralize updates, tasks, and deadlines, enabling clear communication between teams and management.

Respond in a Timely Manner

Timely responses to FDA requests are critical to keeping the regulatory submission process on track. The regulatory planner helps by setting internal deadlines that are ahead of the FDA’s due dates, ensuring ample time for review and approval.

Key Tip:

Use regular progress check-ins to review the status of tasks and keep everything on schedule, allowing time to address any issues that may arise. Make sure that any competing priorities at the team level are addressed by management to make way for the best and most complete and strategic responses possible. Remember: it’s not just the time to getting your submission in to a health authority that matters; it’s the time to its approval, and the IR process is a key component of that process.

Prepare for Follow-Up Requests

Follow-up requests are common in regulatory processes. The regulatory planner ensures that the team remains flexible and prepared for additional questions, even after the initial response has been submitted and all initial questions have been anticipated.

Key Tip:

Keep key team members available after initial submissions to quickly address any follow-up questions, preventing delays in the review process.

Utilize Regulatory Consultants When Needed

For particularly complex FDA requests, the regulatory planner can facilitate the involvement of external consultants. These experts bring specialized knowledge that may be critical to addressing more challenging requests.

Key Tip:

Maintain a list of trusted consultants who can be engaged quickly when specialized expertise is needed to handle difficult or technical questions.

Plan for Document Escalation and Approval

Before any response is submitted to the FDA, it must go through the appropriate internal approval channels. The regulatory planner coordinates this process, ensuring that leadership is aware of the responses being submitted and that all documents have been fully reviewed. In addition, the Regulatory Planner should keep downstream partners such as publishers apprised of progress and when to anticipate key activities related to electronically delivering the response to the health authority.

Key Tip:

Establish a tiered approval system to differentiate between documents that need executive approval and those that can be approved at a lower level, ensuring efficient workflow management.

Conclusion

Managing FDA information requests requires detailed planning, clear communication, and efficient coordination. Leveraging a dedicated regulatory planner helps streamline the entire process—from prioritizing tasks and coordinating teams to tracking progress and facilitating communication. By conducting an overall kickoff meeting for the first batch of questions and holding regular check-ins, companies can maintain momentum and ensure that responses are timely, strategic, and accurate.

Need help managing your information requests from health authorities? Reach out to us at Reach out to us at [email protected] or 888-760-9906.

Read more about writing regulatory submissions!