A Type B meeting (also called a Milestone Meeting or an Entitled Meeting) is a formal meeting between the sponsor and FDA to discuss product development and next steps. These meetings are crucial to keep product development moving forward. Examples of the Type B meetings include pre-IND, end-of-phase (EOP), and pre-NDA/pre-BLA. We will discuss each type below.
What Is a Type B Pre-IND Meeting?
A Type B Pre-IND meeting is a formal meeting between the sponsor and FDA that typically occurs after the completion (or near completion) of the nonclinical studies and initial chemistry, manufacturing, and controls work in the product development program. The goal of this meeting is to review key elements of the data package for FDA to determine whether it is safe to proceed into a proposed clinical study in the US. The format and content of the IND is also discussed.
By engaging with FDA at this stage, sponsors can improve their probability of success in achieving an IND “green light” or IND clearance.
Key Discussion Topics During a Pre-IND Meeting
During a Pre-IND meeting, FDA and the sponsor focus on critical elements of the IND submission, including:
Regulatory
- An overview of the intended indication(s) and target population(s)
- An overview of the mechanism of action of the product
- General questions and clarification of IND requirements
Nonclinical
- Discussion of the animal toxicology, pharmacology, and pharmacokinetic information available on the product
- Adequacy of completed and planned animal studies to support the proposed first-in-human (FIH) trial
- Agreement on any additional nonclinical work needed
Chemistry, Manufacturing, and Controls (CMC)
- The manufacturing information on the product aligns with or exceeds regulatory expectations at this stage of development
- Discussion about the manufacturing of the adequacy of the clinical trial supply
- Plans for scale up for future trials and possible commercialization
- Special protocol assessment procedures can be requested after receiving FDA evaluations to clarify and align on development strategies, helping to avoid costly delays and facilitate smoother progress in product approval
Clinical
- Justification for starting dose and dose-escalation strategy
- Alignment on proposed clinical trial design for Phase 1 (patient population, dose escalation, endpoints)
- Safety monitoring plans and stopping criteria
What Is a Type B End-of-Phase (EOP) Meeting?
A Type B End-of-Phase (EOP) meeting is a formal meeting between a sponsor and FDA that typically occurs after the completion (or near completion) of a clinical stage (Phase 1 or Phase 2) to discuss the results of that stage, what they mean, and discuss proceeding to the next stage of clinical trials with FDA.
By engaging with FDA in EOP meetings, sponsors can gain assurance from FDA that they are on the right track with their clinical development, are ready to move to the next stage, and are aligned on the next clinical study.
Key Discussion Topics During an EOP Meeting
During an EOP meeting, FDA and the sponsor focus on data, including:
For EOP1
The sponsor presents the results of the program, ensuring that:
- Any additional nonclinical studies done after the IND was submitted align with regulatory expectations at this stage of development
- The clinical data collected in Phase 1 is adequate and sufficient to support the proposed Phase 2 clinical trial and Phase 2 program
- The manufacturing information on the product aligns with or exceeds regulatory expectations at this stage of development
For EOP2
The sponsor presents the results of the program, ensuring that:
- The nonclinical study package is either complete or aligns with regulatory expectations at this stage of development
- The clinical data collected in Phase 1 and 2 are adequate and sufficient to support the proposed Phase 3 (pivotal) program
- The manufacturing information on the product aligns with or exceeds regulatory expectations for pivotal trials and there is a plan for commercial supply
What Is a Type B Pre-NDA/Pre-BLA Meeting?
A Type B Pre-NDA/Pre-BLA meeting is a formal meeting between a sponsor and FDA that typically occurs after the completion (or near completion) of Phase 3 (pivotal) clinical trials. The goal of this meeting is to review key elements of the upcoming NDA or BLA submission to ensure that it meets FDA expectations and to discuss the content and format of the marketing application.
By engaging with FDA at this stage, sponsors can refine their submissions, minimize potential deficiencies, and improve the likelihood of acceptance and a smooth review process.
Key Discussion Topics During a Pre-NDA/Pre-BLA Meeting
During a Pre-NDA/Pre-BLA meeting, FDA and the sponsor focus on critical elements of the submission, including:
Clinical Efficacy and Safety Data
The sponsor presents the results of the pivotal study/studies, ensuring that:
- The primary and secondary endpoints align with regulatory expectations.
- The data is sufficient to support the proposed indications.
- Safety concerns, adverse events, and overall risk-benefit assessments are addressed.
Labeling Proposals
The sponsor and FDA discuss:
- Key safety information, including possible contraindications or precautions.
- Proposed warnings, including potential black box warnings.
- Instructions for use, dosing recommendations, and special population considerations.
Chemistry, Manufacturing, and Controls (CMC) Package
The CMC package is a crucial part of the NDA/BLA submission, ensuring that the drug or device’s manufacturing process is consistent and meets FDA quality standards. Discussions typically include:
- Manufacturing processes and facility readiness for commercial production.
- Validation data for product consistency and stability.
- Quality control measures to ensure compliance with Good Manufacturing Practices (GMP).
Why Type B Meetings are Important in the Product Development Process
Engaging with FDA in Type B meetings offer sponsors significant advantages in the product development process:
- Clarifies FDA Expectations: Sponsors gain clarity on specific data requirements, reducing risk and/or unexpected application deficiencies.
- Improves Submission Quality: By addressing potential gaps, sponsors can refine their applications and ensure that all necessary documentation is included.
- Streamlines the Review Process: A well-prepared submission can lead to fewer information requests during review, reducing delays in bringing the product to market.
- Minimizes Regulatory Risks: Early identification of potential concerns allows for proactive adjustments, increasing the likelihood of a positive review outcome.
Need Help Preparing for a FDA Type B Meeting?
Type B meetings are an important milestone in the product development process. By leveraging this opportunity, sponsors can work with FDA and ensure a sound, efficient development plan that sets the stage for a strong NDA/BLA marketing application, and smoother regulatory reviews.
Partnering with experts in regulatory strategy and product development —such as Facet Life Sciences—can provide invaluable guidance in preparing for and maximizing the benefits of FDA interactions throughout development. If your company needs expert support with FDA meetings, contact Facet Life Sciences today to ensure your FDA meeting is positioned for success.
The content above was based on the following guidance. Click the link to it to see more detailed information! If you are not sure how to interpret what you read in the FDA meeting guidance, consult with the experts at Facet – we are happy to help.