Navigating FDA Type B Meetings with CBER: A Comprehensive Guide
MF BIOTECH has supported the preparation and conduct of various FDA Type B meetings and scientific advices, and there are even more considerations than what we could summarize in this guide. MF BIOTECH is happy to support you in making your agency meeting a success.
Navigating the regulatory landscape for biologics and biotechnology products requires careful planning and communication with regulatory agencies like the U.S. Food and Drug Administration (FDA). For developers of biologics seeking guidance and clarification on regulatory requirements, FDA Type B meetings with the Center for Biologics Evaluation and Research (CBER) are crucial. These meetings provide an opportunity for sponsors to discuss specific issues related to product development, clinical trials, and regulatory pathways. In this article, we'll delve into the steps involved in preparing for and conducting a successful FDA Type B meeting with CBER, which is also summarized in Exhibit 1.
EXHIBIT 1 | Step-by-step guide for FDA Type B meetings
Step 1: Determine the Need for a Type B Meeting
The first step in the process is to assess whether a Type B meeting with CBER is suitable for your product development program or whether other FDA meeting types or interactions could be more adequate depending on the meeting objectives and discussion topics.
FDA Type B meetings are typically requested to discuss specific issues or questions related to preclinical or clinical development, manufacturing, or regulatory strategy. Common reasons for requesting include Pre-IND meetings prior to filing of an IND, seeking advice on study design, endpoints, patient population, or clarification on regulatory requirements.
Step 2: Prepare Meeting Request
Once the need for a Type B meeting is identified, sponsors must prepare a meeting request to be submitted to CBER.
The meeting request should include an overview of the product, its development status and specific questions or topics for discussion. It's essential to provide sufficient background information to enable CBER to understand the purpose and scope of the meeting so that the appropriate CBER staff can be identified for participation in the meeting.
As the meeting request contains the list of questions for discussion and objectives of the meeting, the overall strategy for the meeting should be thoroughly prepared in advance.
The meeting requests contains a proposal for meeting dates, the format (in-person, teleconference, or videoconference), and the participant list.
Step 3: Submit Meeting Request to CBER
Meeting requests should be submitted to CBER through FDA's electronic submission gateway or other designated portals, following the agency's guidance on meeting request submissions in compliance with the eCTD format.
It's important to adhere to the specified timelines and content requirements outlined by CBER to ensure timely processing of the meeting request.
Step 4: Pre-Meeting Communication and Planning
CBER typcially responds to meeting requests within 21 days after receipt.
If the meeting requests is granted, CBER will provide all meeting details. As per FDA’s meeting guidance, the meeting should be scheduled within 60 days, however, later dates are common depending on the availability of CBER staff. If needed, sponsors may engage in pre-meeting communication with CBER to discuss logistical details, such as scheduling, format (in-person, teleconference, or videoconference), and participant list.
If the meeting is denied or for other reasons, sponsors may have the opportunity to address any questions or concerns raised by CBER regarding the meeting request or provide clarification on submitted documents.
Step 5: Submit Meeting Package
The preparation of the meeting package typically starts at the time the meeting request has been submitted (Step 3) or earlier.
Besides the meeting information, the meeting package must contain data summaries for each question to support the discussion. The content of the meeting package should be closely aligned with the information provided in the meeting request, in particular the list of questions.
The meeting package must be submitted to CBER and received at least 30 days prior to the agreed meeting date.
Step 6: Preliminary Responses from FDA
The sponsor receives FDA’s preliminary responses to the meeting package at least 2 days prior to the meeting. This time should be blocked for all sponsor team members who participate in the meeting or contribute to its preparation.
The sponsor team should thoroughly review the responses and selects those topics that should be discussed with the agency during the meeting. As best practice, the sponsor prepares presentation slides to support the discussion and submits them to FDA prior to the meeting.
In addition, the sponsor anticipates critical discussion points of the meeting and aligns potential response and backup strategies before the meeting.
Step 7: Conduct the Type B Meeting
On the scheduled meeting date, sponsors, along with relevant stakeholders such as key team members, experts, and key opinion leaders, participate in the Type B meeting with CBER representatives.
During the meeting, sponsors present the previously selected questions or topics for discussion (Step 6).
Step 8: Final Meeting Minutes
Following the Type B meeting, FDA issues the final meeting minutes within 30 days after the meeting. The preliminary responses provided by FDA (Step 6) are the basis for the meeting minutes.
It is formally not required that sponsors prepare meeting minutes, however, some sponsors provide their meeting minutes to FDA to facilitate alignment of their understanding about the key discussion points, decisions, and action items agreed upon during the meeting.
Step 9: Follow-Up and Implementation
After the Type B meeting, sponsors should promptly address any action items or follow-up tasks identified during the meeting.
This may include revising study protocols, updating regulatory submissions, or addressing specific concerns raised by CBER. Effective communication and collaboration with CBER throughout the follow-up process are critical to ensuring alignment with regulatory expectations and advancing the product development program.
Conclusion
Navigating FDA Type B meetings with CBER requires careful planning, preparation, and collaboration between sponsors and regulatory authorities. By following the steps outlined in this guide, sponsors can maximize the value of these meetings and obtain valuable feedback and guidance to support the development and regulatory approval of biologics and biotechnology products. Effective communication and engagement with CBER are essential for achieving regulatory success and bringing innovative therapies to patients in need.