For life sciences companies navigating the FDA regulatory landscape, Type A meetings are generally considered informative meetings focused on resolving issues. They primarily apply to the drug and biologic development process under the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Type A meetings serve as critical touchpoints to resolve urgent and time-sensitive issues that may hinder a drug development program. These meetings provide sponsors with a structured opportunity to address roadblocks such as clinical holds and dispute resolutions, ensuring that development can proceed without unnecessary delays. Below, we will take an in-depth look at the nuances of FDA Type A meetings, including their purpose, process, and key considerations for sponsors.
What is a Type A Meeting?
A Type A meeting is a high-priority discussion between FDA and a sponsor, intended to address stalled development programs. These meetings are granted when a company faces significant regulatory challenges, including:
- Clinical Holds – When FDA halts a clinical trial due to safety concerns, a Type A meeting provides a platform to determine how the sponsor can lift the hold by modifying the study protocol or conducting additional safety assessments.
- Dispute Resolutions – If a sponsor disagrees with an FDA decision, such as trial design requirements or safety concerns, a Type A meeting allows both parties to discuss the issue and reach a resolution that aligns with regulatory expectations.
- Stalled Development Programs – If a development program has been placed on hold or is otherwise delayed due to regulatory concerns, sponsors can use a Type A meeting to seek FDA guidance on necessary steps for advancement.
Timeline and Scheduling
The urgency of a Type A meeting is reflected in its expedited scheduling process. Sponsors must submit a formal combined meeting request and background package to FDA, which will be reviewed and either granted or denied. If granted, FDA will schedule the meeting within 30 calendar days of receiving the request, emphasizing the time-sensitive nature of these discussions.
What Happens During a Type A Meeting?
Type A meetings are structured discussions that follow a formal agenda agreed upon beforehand. The process typically includes:
- Submission of Meeting Request – Sponsors must provide a detailed meeting request that outlines the issue at hand, supporting data, and a proposed agenda. The request should clearly articulate the need for regulatory input and propose possible solutions.
- FDA Review and Scheduling – Upon review, FDA will determine if the meeting is necessary and will schedule it within the 30-day timeframe if granted.
- Pre-Meeting Preparation – The team attending the Type A meeting should rehearse responses and possible backup plans to make the most of the meeting.
- The FDA Meeting – Conducted either in person, via teleconference, or virtually, the meeting itself is concise and focused. Discussions center on resolving the identified issue, with FDA representatives providing direct feedback and regulatory guidance.
- Post-Meeting Summary – Following the meeting, FDA will issue formal meeting minutes within 30 days, summarizing the key takeaways, agreed-upon actions, and next steps for the sponsor.
Key Considerations for Sponsors to Achieve Best Results from a FDA Type A Meeting
Given the high stakes of a Type A meeting, preparation is critical. Here are some best practices for ensuring a productive discussion:
- Clearly Define the Issues – A well-structured combined meeting request and background package that clearly outlines the regulatory challenges and desired outcomes improves the likelihood of actionable next steps.
- Provide Comprehensive Data – Supporting documentation should be concise, thorough, relevant, and directly tied to the issue under discussion.
- Anticipate FDA Questions – Sponsors should prepare for potential FDA concerns and push-back. Be ready to provide well-supported responses during the meeting.
- Engage Regulatory Experts – Working with regulatory consultants, such as those at Facet Life Sciences, can help Sponsors navigate the complexities of a Type A meeting, ensuring they maximize the opportunity for resolution and a clear path forward.
What Happens if FDA Denies a Request for a Type A Meeting ?
If FDA does not grant the request for a Type A meeting, the agency may (in order of likelihood):
- Reclassify the Meeting Type – FDA may determine that the request does not meet the criteria for a Type A meeting but instead qualifies as a Type B or Type C meeting, which have different scheduling timelines and purposes.
- Provide Guidance via Written Response (WRO) – If FDA believes the issues raised in the request can be adequately addressed in writing, they may provide sponsors with a written response instead of granting a meeting.
- Request Additional Information – FDA may determine that the meeting request lacks sufficient detail or supporting data. In this case, sponsors may revise and resubmit the request with the necessary clarifications.
- Provide an Outright Denial – If FDA concludes that the request does not meet the requirements for a Type A meeting and does not warrant a written response or reclassification, the meeting will simply be denied.
Next Steps for Sponsors when Denied a Type A Meeting
If a Type A meeting request is denied, sponsors should:
- Carefully review FDA’s rationale for the denial.
- Consider submitting a revised request with additional supporting information.
- Engage regulatory experts, such as Facet Life Sciences, to refine the strategy for engaging with FDA more effectively.
While a denied Type A meeting request can appear to be a setback, Sponsors still have opportunities to obtain FDA guidance through alternative pathways.
Need Help Requesting or Preparing for a FDA Type A Meeting ?
FDA Type A meetings play a crucial role in addressing urgent regulatory issues that can stall drug development. By understanding the process, preparing thoroughly, and leveraging expert guidance, sponsors can use these meetings effectively to remove roadblocks and keep their programs moving forward. Whether resolving a clinical hold or seeking dispute resolution, a well-executed Type A meeting can be instrumental in achieving regulatory success.
Schedule a Conversation with Facet Life Sciences
The content above was based on the following guidance. Link to it to see more detailed information! If you are not sure how to interpret what you read in the guidance, consult with the experts at Facet!