When developing a new drug, early engagement with FDA through a Pre-Investigational New Drug (Pre-IND) meeting can set the stage for a smoother regulatory process. This meeting is essential to avoid clinical holds and prevent costly errors in the submission process. It offers an opportunity to gain critical insight into FDA’s expectations before submitting an IND application. But success depends on more than just securing a meeting—it’s about extracting actionable guidance to move forward confidently.

Understanding the Pre-IND Meeting Process

A Pre-IND meeting is an optional but highly valuable step in drug development. It allows sponsors to discuss their development plan, seek FDA’s perspective on key issues, and identify potential regulatory hurdles early. This can significantly reduce delays and costly missteps down the line.

How to Submit a Pre-IND Meeting Request

The first step in the Pre-IND meeting process is determining whether such a meeting is necessary. Sponsors should assess whether they have specific scientific or regulatory questions that require FDA input and whether obtaining guidance at this stage will provide clarity on their path forward. If a Pre-IND meeting is deemed beneficial, the next step is preparing the meeting request. A written request must be submitted to the appropriate FDA review division at least 60 days before the desired meeting date. The request should clearly justify the need for the meeting, specify the type of feedback being sought, suggest three preferred dates, and indicate the meeting format (face-to-face, videoconference, teleconference, or WRO (written response only). The meeting request should be comprehensive and organized in order to ensure it is effective.

Once FDA grants the request, the sponsor must submit a detailed briefing package at least 30 days before the scheduled meeting. This package should include a comprehensive product overview describing the investigational drug, its mechanism of action, and the proposed indication. Additionally, the briefing package should contain a summary of the completed pre-clinical and clinical studies (if applicable), a list of well-defined questions, and any supporting data that is relevant to the issues being discussed.

The Role of Pre-IND Meetings in Drug Development

Pre-IND meetings play a critical role in the drug development process. They provide an opportunity for sponsors to seek critical feedback on their development plans and clarify regulatory requirements. The meetings are most effective when focused on specific scientific or regulatory issues, such as clinical trial design and endpoint selection, pharmacology studies, toxicology studies, manufacturing challenges, dosing selection, and data requirements for the IND application.

Pre-IND meetings can reduce time to market by identifying and avoiding unnecessary studies, ensuring that necessary studies are designed to provide useful information, and gaining FDA support for a proposed strategy. They can also minimize the potential for a clinical hold, provide an opportunity for creative exchange of ideas, obtain regulatory insight, minimize costs, and clearly define endpoints and goals of the development program.

Conducting a Successful Pre-IND Meeting

Conducting a successful Pre-IND meeting requires careful planning and preparation. Sponsors should ensure that the meeting request is clear and concise, and that the briefing package is well-organized and easy to follow. During the meeting, sponsors should ask for clarification, be respectful and not argumentative, listen closely, take excellent notes, and be objective.

After the meeting, FDA will provide meeting minutes to the sponsor within 30 days unless the meeting is written response only (WRO). If a WRO has been requested or FDA chooses to provide WRO, FDA provides their written comments to the meeting request within 60 days from their receipt of the meeting request .

Maximizing the Value of FDA Feedback

A Pre-IND meeting is not just a procedural step—it is a strategic opportunity to gain valuable regulatory insight. To ensure that the meeting results in meaningful guidance, sponsors should frame their questions clearly and concisely to receive definitive answers from FDA. Prioritizing the most critical issues is essential, as this ensures that FDA’s input focuses on aspects that directly impact the drug development program. Engaging with Facet Life Science, an organization that has extensive experience successfully navigating Pre-IND meetings with FDA can go a long way toward maximizing the value of the meeting.

Measuring Success: Having a Clear Path Forward

The true measure of success in a Pre-IND meeting is not getting a “yes” answer to all your questions but obtaining a clear and actionable path forward. The central question sponsors should ask themselves is: “Do I have the answers I need to do what I need to do next?” 

Success in this context means addressing specific questions related to proposed study design, endpoints, and development approach, and receiving confirmation that these elements are on track. It also involves identifying any gaps that must be addressed before proceeding and gaining confidence that the drug development strategy aligns with FDA’s expectations. If sponsors leave the meeting with a well-defined action plan and no lingering uncertainties about the next steps, then the Pre-IND meeting has been a success.

Moving from Pre-IND to IND Submission

After the meeting, it is essential to reflect on FDA’s feedback and make adjustments to your development  plan, as needed. If FDA raises concerns, sponsors should address those concerns proactively rather than waiting for FDA comments during the IND review period.

Expert Guidance Preparing for Your Pre-IND Meeting

Facet Life Sciences specializes in regulatory strategy and FDA interactions, helping sponsors navigate complex drug development pathways with confidence. Having expert scientifically- based regulatory consultants, each with over 15 years of experience working with FDA can significantly enhance preparation and improve the chances of a successful FDA interaction. If you are preparing for a Pre-IND meeting, our team can help craft a compelling meeting request, develop a strong briefing package, and interpret FDA’s feedback to accelerate your progress. Talk to an expert at Facet Life Sciences to discuss your regulatory needs.

 

FDA References