FDA Meeting Types Explained: Complete Guide to Type A, B, C, and D Meetings

Requesting an FDA meeting at the wrong time-or requesting the wrong type-can delay your drug development program by months. Understanding the four FDA meeting types is essential for any regulatory professional navigating the drug approval process.

FDA formal meetings are categorized into Type A, Type B, Type C, and Type D, each with different purposes, timelines, and procedural requirements. Choosing correctly determines how quickly FDA responds and how substantively they engage with your questions.

In this guide, you'll learn:

• The key differences between Type A, B, C, and D FDA meetings
• When to request each meeting type during drug development
• FDA response timelines and scheduling requirements
• How to prepare meeting packages that get results
• Common mistakes that delay regulatory interactions

What Are FDA Formal Meetings?

FDA formal meetings are scheduled interactions between drug sponsors and FDA review divisions to discuss specific development questions. These meetings are governed by FDA guidance documents and the Prescription Drug User Fee Act (PDUFA) commitments.

Unlike informal communications, formal meetings provide:

• Written FDA responses to your questions
• Documented agreements that guide development
• Clear timelines mandated by PDUFA
• Binding commitments (in most cases)

The FDA categorizes formal meetings into four types based on urgency and development stage. Each type has distinct request procedures, response timelines, and scheduling requirements.

Type A Meeting FDA: Critical Path Meetings

A Type A meeting FDA designation is reserved for the most time-sensitive situations-when a development program is stalled or a critical safety issue requires immediate FDA input.

When to Request a Type A Meeting

Type A meetings are appropriate when:

• A clinical hold has been placed on your IND
• A Special Protocol Assessment (SPA) dispute requires resolution
• A complete response letter requires immediate discussion
• A critical safety issue affects ongoing trials

Type A meetings are not for routine development questions. FDA reserves this category for situations where delay would significantly harm patients or prevent program advancement.

Type A Meeting Timelines

The 30-day scheduling requirement makes Type A meetings the fastest formal interaction with FDA. However, the bar for approval is high-FDA will decline Type A designation for matters that don't meet urgency criteria.

Type A Meeting Request Tips

To increase approval likelihood:

• Clearly articulate why the matter is urgent
• Explain the development impact of delay
• Document how the issue blocks advancement
• Propose specific questions requiring FDA input

Type B Meeting FDA: Key Development Milestones

A Type B meeting FDA designation covers the most common formal meetings during drug development. These meetings occur at critical decision points where FDA input shapes the regulatory pathway.

Type B Meeting Categories

Type B meetings include:

Pre-IND Meetings

The pre-IND meeting occurs before submitting an Investigational New Drug application. This meeting helps sponsors understand FDA's expectations for first-in-human studies and identify potential issues before formal review.

End-of-Phase 1 Meetings

For certain therapeutic areas, an end-of-phase 1 meeting helps sponsors plan phase 2 studies based on initial safety and pharmacokinetic data.

End-of-Phase 2 Meetings

The end of phase 2 meeting is arguably the most important FDA interaction. This meeting establishes agreement on phase 3 trial design, endpoints, and the evidence package needed for approval.

Pre-NDA/Pre-BLA Meetings

The pre-NDA meeting (or pre-BLA for biologics) occurs before submission of a marketing application. This meeting confirms submission format, content expectations, and any outstanding scientific issues.

Type B Meeting Timelines

Pre-IND Meeting: Essential Preparation

A successful pre-IND meeting sets the foundation for your entire clinical development program. FDA expects sponsors to present:

• Summary of pharmacology and toxicology data
• Proposed clinical protocol for phase 1
• Chemistry, Manufacturing, and Controls (CMC) overview
• Specific questions about IND requirements

The pre-IND meeting is your opportunity to identify potential clinical holds before they happen. Come prepared with specific questions-vague requests result in vague FDA responses.

End of Phase 2 Meeting: Critical Success Factors

The end of phase 2 meeting determines whether your phase 3 program will support approval. This meeting should address:

• Primary and secondary endpoint selection
• Statistical analysis plan fundamentals
• Patient population and enrollment criteria
• Safety database requirements
• Regulatory pathway (standard vs. accelerated)

Misalignment at the end of phase 2 meeting is one of the most common causes of failed NDAs. Investing significant effort in this meeting package pays dividends throughout phase 3.

Pre-NDA Meeting: Final Alignment

The pre-NDA meeting confirms readiness for NDA or BLA submission. Key discussion topics include:

• eCTD structure and content expectations
• Labeling discussions
• Risk Evaluation and Mitigation Strategy (REMS) requirements
• Advisory committee expectations
• Post-marketing commitments

FDA increasingly expects sponsors to use pre-NDA meetings to resolve outstanding questions-not to introduce new issues.

Type C Meeting FDA: All Other Formal Meetings

A Type C meeting FDA designation covers formal meetings that don't qualify as Type A or Type B. These meetings address important development questions that aren't tied to critical milestones.

When to Request a Type C Meeting

Type C meetings are appropriate for:

• CMC manufacturing changes
• Non-clinical study design questions
• Post-marketing requirement discussions
• Pediatric development planning
• Labeling updates

Type C meetings have longer timelines than Type A or B, reflecting their lower priority in FDA's queue.

Type C Meeting Timelines

While Type C meetings take longer to schedule, they still provide documented FDA feedback that can guide development decisions.

Type D Meeting FDA: Written Response Only

A Type D meeting FDA designation provides written FDA responses without a face-to-face or teleconference meeting. This category is appropriate when questions can be addressed without interactive discussion.

When Type D Makes Sense

Type D is appropriate when:

• Questions are straightforward
• Interactive discussion isn't necessary
• Written response provides sufficient guidance
• Timeline flexibility exists

Type D Meeting Timelines

Type D meetings can be converted to Type C (with an actual meeting) if FDA determines interactive discussion is necessary based on the questions submitted.

FDA Meeting Type Comparison

How to Request an FDA Meeting

Meeting Request Package Contents

Every FDA meeting request should include:

1. Meeting type and purpose

- Clearly identify Type A, B, C, or D

- Explain why this designation is appropriate

1. Brief background

- Drug/biologic description

- Development status

- Relevant regulatory history

1. Specific questions

- Number questions clearly

- Focus on decisions requiring FDA input

- Avoid open-ended questions

1. Sponsor position

- State your proposed approach for each question

- Provide supporting rationale

1. Supporting data

- Include necessary information for FDA review

- Reference relevant IND sections or submissions

Common Meeting Request Mistakes

Mistake 1: Wrong meeting type

Requesting Type A for routine questions wastes time when FDA declines the designation.

Mistake 2: Vague questions

"What does FDA think about our development plan?" generates unhelpful responses. Specific questions get specific answers.

Mistake 3: Insufficient background

FDA reviewers may not know your program history. Provide enough context for informed responses.

Mistake 4: Too many questions

Overwhelming meeting packages reduce response quality. Focus on the most critical decisions.

Mistake 5: Missing sponsor positions

FDA expects you to propose solutions, not just ask questions. State your approach and ask for agreement.

FDA Meeting Best Practices

Before the Meeting

• Submit the meeting package on time (60 days before for Type B)
• Ensure all questions have clear sponsor positions
• Prepare responses to likely FDA pushback
• Assign roles for the meeting (lead, note-taker, subject experts)
• Conduct internal dry runs

During the Meeting

• Start with brief introductions
• Confirm FDA has no additional questions before starting
• Address questions in order unless FDA requests otherwise
• Take detailed notes-meeting minutes are binding
• Clarify any ambiguous FDA statements before concluding

After the Meeting

• Review draft meeting minutes carefully
• Request corrections within 30 days if needed
• Document any verbal agreements in meeting minutes
• Update development plans based on FDA feedback
• Ensure cross-functional teams understand commitments

Special Meeting Types

Breakthrough Therapy Meetings

Sponsors with Breakthrough Therapy Designation receive enhanced FDA engagement, including:

• More frequent Type B meetings
• Intensive guidance on development program
• Senior FDA leadership involvement
• Pre-submission meeting before NDA/BLA

Fast Track Meetings

Fast Track Designation provides:

• More frequent Type B meetings
• Rolling review eligibility
• Enhanced FDA communication

Pre-Submission Meetings for Complex Products

Gene therapies, cell therapies, and combination products may qualify for additional pre-submission meetings to address manufacturing and regulatory complexity.

Key Takeaways

Next Steps

Preparing for an FDA meeting requires careful attention to submission format and regulatory requirements. Whether you're assembling a pre-IND meeting package or preparing for a pre-NDA meeting, ensuring your documentation meets FDA expectations is critical.

Organizations managing regulatory submissions benefit from automated validation tools that catch errors before gateway rejection. Assyro's AI-powered platform validates eCTD submissions against FDA, EMA, and Health Canada requirements, providing detailed error reports and remediation guidance before submission.

Sources:

• FDA Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance
• 21 CFR Part 312 - Investigational New Drug Application
• PDUFA Commitment Letters

Last updated: January 25, 2026