data.

Pre-NDA/Pre-BLA: Ensures completeness of marketing application data before submission.

These meetings significantly influence approval timelines. Missing a Type B opportunity can result in poor submission outcomes or unnecessary study duplication.

Timeline for Requesting a Type B Meeting

According to the FDA’s guidance for industry, sponsors must follow specific timing rules for requesting Type B meetings:

• Meeting request submission: At least 60 days before the desired meeting date.
• FDA confirmation or denial: Within 14 calendar days of receiving the request.
• Scheduling: If accepted, FDA schedules the meeting within 60 calendar days from the receipt of the request.
• Briefing package submission: Must be provided at least 30 days before the confirmed meeting date.

Failing to adhere to this timeline can lead to delays or the meeting being declined altogether.

Continue with Submission Format, Meeting Examples, and FDA Process Flow

Formatting Your FDA Meeting Request

The meeting request should be submitted in eCTD format (if applicable) through the Electronic Submissions Gateway (ESG) and must include the following:

• Type of meeting requested (e.g., pre-IND Type B)
• Proposed agenda and list of questions, grouped by functional area
• Preferred dates and times (3–5 options)
• Participants from the sponsor and suggested FDA attendees (if known)
• Format of the meeting (face-to-face, teleconference, or written response only)
• Application number if available (IND/NDA/BLA)
• Cover letter and proposed meeting minutes template

Sponsors must be specific in their meeting objectives and questions to ensure focused and actionable FDA feedback.

Real-World Example: EOP2 Meeting Timeline

A sponsor developing a novel inhaled corticosteroid prepared for an end-of-Phase 2 meeting. The timeline followed:

• Meeting request submitted: March 1
• FDA response confirming meeting: March 10
• Meeting scheduled: April 29
• Briefing package submitted: March 29
• Meeting held via teleconference with CMC and clinical experts

The sponsor received critical guidance on PK comparability and finalized Phase 3 designs based on FDA’s feedback, enabling a smoother IND amendment and accelerated NDA preparation.

Best Practices for Submission and Scheduling

• Submit meeting requests electronically in the correct format using FDA ESG
• Ensure all questions are clear and provide background context
• Propose flexible dates and avoid public holidays or agency closure periods
• Prepare a response plan in case FDA offers Written Response Only (WRO)
• Assign a regulatory liaison to track communications and submissions

FDA’s Internal Process Flow for Type B Meetings

Milestone	Responsible Party	Timeline
Meeting request review	FDA Regulatory Project Manager (RPM)	Within 14 days of request
Meeting date scheduling	FDA division and sponsor coordination	Within 60 days
Briefing package review	FDA review teams (CMC, clinical, etc.)	Ongoing until meeting date
Issuance of minutes	FDA RPM	Within 30 days post-meeting

Interaction with Other Regulatory Milestones

Type B meetings should be strategically timed with:

• Submission of protocol amendments
• Initiation of Phase 3 studies
• CMC scale-up milestones
• Pre-NDA readiness checks

Aligning these meetings with development decisions reduces regulatory risk and avoids rework.

Where to Find Additional Guidance

Refer to Be Part of Research UK and FDA’s own Meeting Guidance Documents for templates and real-world case references that can improve your submission accuracy.

Conclusion: Timing and Clarity Are Everything

A timely and well-formatted FDA Type B meeting request can shape your regulatory pathway, prevent costly delays, and lead to successful product development outcomes. By understanding the timelines, structure, and internal FDA process, sponsors can position their programs for efficient advancement toward marketing applications.