When developing a new drug or biologic, timely and strategic engagement with FDA can be the key to a smoother regulatory pathway. While Type A and Type B meetings are often tied to critical milestones, Type C meetings serve as a “catch-all” opportunity for sponsors to seek FDA input on a wide range of topics at various stages of development. These meetings offer flexibility in addressing scientific discussions, protocol amendments, data interpretations, and more, making them a valuable tool for sponsors navigating complex regulatory challenges.
What are Type C FDA Meetings?
A Type C meeting with FDA is a formal, non-milestone meeting that allows sponsors to discuss important aspects of their drug development program that do not fall under the scope of Type A or Type B meetings. These formal meetings are crucial for navigating the drug development process. Post-FDA regulatory action, these meetings help sponsors address safety issues and strategize on development paths.
These discussions can include:
- Study design: Scientific discussions about endpoint selection, possible biomarkers, complicated composite endpoints and the acceptability of proposed endpoints to support regulatory decision-making.
- Protocol amendments: Ensuring clinical trial design and modifications align with FDA expectations.
- Data interpretation and regulatory strategy: Aligning on study results interpretations and their implications for regulatory submissions.
- Pre-submission or post-submission clarifications: Addressing uncertainties before or after an IND submission.
- Follow-up to previous FDA comments: Seeking additional guidance on review feedback.
- Manufacturing and quality concerns: Discussing changes in manufacturing processes, new material sources, or facility changes that could impact product quality and regulatory compliance.
- Drug Product and Drug Substance Specifications: Aligning on FDA expectations for setting manufacturing specifications, including analytical methods, acceptance criteria, and control strategies to ensure product quality and compliance.
The Value of a Type C Meeting in the Drug Development Process
One of the most significant advantages of a Type C meeting is its flexibility. Unlike Type A or Type B meetings, which are often bound to strict regulatory milestones, Type C meetings provide sponsors with an opportunity to proactively engage with FDA at any point in development. This can be particularly useful when:
- Discussing nonclinical study designs, species selection, and nonclinical development programs
- Obtaining input on new efficacy endpoints
- Aligning with FDA expectations on statistical analysis plans
- Adjusting clinical trial protocols based on emerging data
- Seeking input on novel manufacturing approaches or quality concerns
- Addressing regulatory uncertainties before submitting an application
By leveraging a Type C meeting early, sponsors can mitigate risks, reduce costly delays, and ensure that development stays on track. These meetings are also valuable for discussing the overall development program, especially for products with breakthrough therapy designations.
When to Request an FDA Type C Meeting
A Type C meeting is a versatile option for sponsors needing FDA input on topics that don’t fit within the scope of Type A or Type B meetings. Sponsors should consider requesting a Type C meeting when they need feedback on these non-critical yet important aspects of their drug development program. To ensure timely scheduling, it’s advisable to submit the meeting request approximately 75 days before the desired meeting date. This proactive approach allows for thorough preparation and a more productive discussion with FDA.
Scheduling and Timelines for a Meeting Request
Type C meetings follow FDA-established timelines:
- FDA will respond to a meeting request within 75 days of receiving it.
- Meetings can be conducted as face-to-face discussions, conference calls, or written responses only (WRO).
- The background package can be submitted at the time of the meeting request or 47 days before the date of the meeting (or expected written response in the case of a WRO meeting)
- Good questions, a well-structured meeting request, and data-supported briefing document are the keys to a productive discussion.
Maximizing the Outcome of a Type C FDA Meeting
To get the most value from a Type C meeting, sponsors should:
- Clearly define objectives: Specify the key questions and regulatory challenges you need FDA input on.
- Focus on objectives: Limit the agenda to essential topics for precise, actionable feedback from the FDA.
- Submit a strong briefing package: Provide clear, well-organized data to support the discussion.
- Engage regulatory experts: Work with experienced professionals, like Facet Life Sciences, to craft compelling questions to ensure you get the answers you need to move your program forward.
- Follow up effectively: Address any FDA feedback and integrate it into the development plan.
How Facet Life Sciences Can Help You Prepare for a FDA Type C Meeting
At Facet Life Sciences, we guide sponsors through the types of FDA meetings to ensure meaningful and efficient interactions. Our regulatory experts assist in meeting strategy and preparation, authoring meeting requests and background packages, running the meeting, serving as scientific experts, and post-meeting follow up. Each part of the process is important to ensure you make the most of FDA interaction.
If you’re considering a Type C meeting for your development program, contact Facet Life Sciences today for expert support in navigating you “to and through” FDA!