Pre-NDA Meeting Guide: How to Prepare for Your FDA Pre-Submission Meeting
A pre-NDA meeting is a formal Type B meeting with FDA that occurs before submitting a New Drug Application (NDA), designed to confirm submission readiness and resolve outstanding scientific or regulatory questions. FDA must schedule these meetings within 60 calendar days of request, and they typically occur 3-5 months before NDA submission. A well-executed pre-NDA meeting prevents refuse-to-file decisions, reduces review cycles, and accelerates time to approval by aligning sponsors with FDA on submission format, content expectations, and any unresolved issues that could delay approval.
A pre-NDA meeting is a formal Type B meeting with FDA that occurs before submitting a New Drug Application (NDA), designed to confirm submission readiness and resolve outstanding scientific or regulatory questions. This critical milestone meeting helps sponsors align with FDA on submission format, content expectations, and any unresolved issues that could delay approval.
For regulatory teams preparing their first marketing application, the pre-NDA meeting represents one of the most important FDA interactions in the entire drug development program. A well-executed pre-NDA meeting can prevent refuse-to-file decisions, reduce review cycles, and accelerate time to approval.
In this guide, you'll learn:
- What a pre-NDA meeting is and when to request one
- FDA timelines for pre-NDA meeting scheduling and responses
- How to prepare an effective pre-NDA meeting package
- Key topics to address during your FDA pre-submission meeting
- Common mistakes that undermine pre-NDA meeting success
What Is a Pre-NDA Meeting FDA?
A pre-NDA meeting is a formal Type B regulatory meeting between a drug sponsor and the FDA that occurs in the final stages of development-typically 2-6 months before planned NDA submission-to confirm submission readiness, resolve outstanding scientific or regulatory questions, and align on eCTD format, content expectations, and regulatory pathway.
A pre-NDA meeting FDA is a formal regulatory meeting classified as a Type B meeting under FDA's meeting guidance. The pre-NDA meeting occurs in the final stages of drug development, typically 2-6 months before the sponsor plans to submit their NDA to the FDA.
Key characteristics of a pre-NDA meeting:
- Classified as a Type B meeting with 60-day scheduling timeline
- Focuses on submission readiness and outstanding questions
- Covers eCTD format, content expectations, and regulatory pathway
- Results in binding meeting minutes that guide NDA preparation
- Required for most first-time NDA sponsors (strongly recommended for all)
FDA must schedule pre-NDA meetings within 60 calendar days of receiving the meeting request, per PDUFA VII commitment letters. FDA will provide preliminary responses at least 2 calendar days before the scheduled meeting.
The pre-NDA meeting is your last opportunity to align with FDA before submitting hundreds of thousands of pages of clinical data. Misalignment at this stage often results in refuse-to-file (RTF) decisions or significant information requests during review. Use this meeting strategically to resolve critical questions definitively rather than leaving issues for FDA reviewers to discover during the formal review cycle.
Pre-NDA Meeting vs Pre-BLA Meeting: Understanding the Difference
Sponsors developing biological products will request a pre-BLA meeting rather than a pre-NDA meeting. While the meeting structure and purpose are nearly identical, there are important distinctions.
Pre-NDA Meeting vs Pre-BLA Meeting Comparison
| Feature | Pre-NDA Meeting | Pre-BLA Meeting |
|---|---|---|
| Application Type | New Drug Application (NDA) | Biologics License Application (BLA) |
| Review Division | CDER (Center for Drug Evaluation and Research) | CBER (Center for Biologics Evaluation and Research) or CDER |
| Product Types | Small molecule drugs, certain complex drugs | Vaccines, blood products, gene therapies, monoclonal antibodies |
| Meeting Type | Type B | Type B |
| Scheduling Timeline | 60 calendar days | 60 calendar days |
| Key Focus Areas | CMC, clinical data, labeling | Manufacturing complexity, lot release, potency assays |
| Typical Timing | 2-6 months before NDA submission | 2-6 months before BLA submission |
Both pre-NDA and pre-BLA meetings serve the same fundamental purpose: ensuring the sponsor and FDA are aligned on submission expectations before the marketing application is filed. The preparation process, meeting request format, and procedural requirements are essentially identical.
“Important: Some biological products are now reviewed by CDER rather than CBER. Confirm your review division early in development to ensure you're engaging with the correct FDA contacts for your pre-BLA meeting.
When to Request a Pre-NDA Meeting
Timing your pre-NDA meeting request correctly is critical. Request too early, and you won't have final data to discuss. Request too late, and you risk delaying your NDA submission.
Pre-NDA Meeting Timeline: Key Milestones
| Milestone | Timing Relative to NDA Submission |
|---|---|
| Complete Phase 3 primary analysis | 8-12 months before |
| Prepare pre-NDA meeting request | 6-8 months before |
| Submit meeting request to FDA | 5-7 months before |
| FDA responds to meeting request | Within 21 calendar days |
| Pre-NDA meeting scheduled | Within 60 calendar days of request |
| Meeting conducted | 3-5 months before NDA |
| Meeting minutes issued | Within 30 days of meeting |
| NDA submission | Target date |
Optimal Pre-NDA Meeting Timing
The ideal pre-NDA meeting occurs when:
- Phase 3 data is available - Primary efficacy and safety analyses are complete
- CMC is finalized - Manufacturing process and specifications are locked
- Labeling draft exists - Proposed label language is ready for discussion
- Sufficient time remains - At least 3 months between meeting and planned submission
- Outstanding questions are identified - You have specific issues requiring FDA input
Trigger Events for Pre-NDA Meeting Request
Consider requesting your pre-NDA meeting when:
- Phase 3 top-line results are positive
- All pivotal studies have completed
- Manufacturing validation is complete or near-complete
- Your regulatory team has identified submission readiness gaps
- You need clarity on expedited review pathway eligibility
Pre-NDA Meeting Request: How to Submit
The FDA pre-submission meeting request process follows standardized procedures outlined in FDA guidance. A well-prepared meeting request increases the likelihood of FDA acceptance and a productive meeting.
Pre-NDA Meeting Request Package Contents
Your pre-NDA meeting request must include:
1. Administrative Information
- Sponsor name and contact information
- IND number and drug name
- Proposed meeting type (Type B)
- Proposed meeting date range (3 options recommended)
- List of proposed attendees
2. Meeting Background
- Brief product description
- Development program summary
- Current regulatory status
- Relevant previous FDA interactions
3. Specific Questions
- Numbered list of questions requiring FDA input
- Clear sponsor position for each question
- Supporting rationale for sponsor positions
- Questions organized by topic (CMC, clinical, labeling, etc.)
4. Supporting Documentation
- Summary of Phase 3 efficacy data
- Integrated safety summary
- CMC overview
- Proposed labeling
- eCTD submission plan
Pre-NDA Meeting Question Best Practices
Effective pre-NDA meeting questions follow specific principles:
| Good Questions | Poor Questions |
|---|---|
| "Does FDA agree that the proposed primary endpoint of [X] is acceptable for this indication?" | "What endpoint should we use?" |
| "Does FDA agree that the proposed Phase 3 sample size of 500 patients provides adequate safety data?" | "Is our safety database big enough?" |
| "Based on the proposed label language in Attachment A, does FDA have concerns with the indication statement?" | "What should our label say?" |
| "Is FDA aligned with our proposed eCTD structure outlined in Attachment B?" | "How should we organize the NDA?" |
Rule of thumb: Every question should include your proposed approach and ask FDA to agree, disagree, or provide specific feedback.
Sponsors who structure questions with three parts-"We propose [X], the rationale is [Y], do you agree?"-receive the most actionable FDA feedback. Vague questions generate vague responses that often require follow-up written correspondence, delaying your submission timeline. Invest time in crafting crystal-clear questions with supporting rationale before submitting your meeting request.
What to Discuss in Your Pre-NDA Meeting
The FDA pre-submission meeting agenda should cover all critical topics that could affect submission acceptance and review timeline. Prioritize topics where FDA alignment is essential.
Essential Pre-NDA Meeting Topics
1. eCTD Structure and Format
- Proposed Module organization
- Hyperlink strategy
- Document granularity
- Regional-specific requirements
2. Clinical Data Presentation
- Integrated summary of efficacy (ISE) approach
- Integrated summary of safety (ISS) structure
- Pooling strategy for multiple studies
- Subgroup analysis plans
3. CMC Documentation
- Drug substance and drug product specifications
- Manufacturing site information
- Stability data requirements
- Container closure system
4. Labeling
- Proposed indication language
- Dosing recommendations
- Warnings and precautions
- Patient labeling requirements
5. Risk Management
- REMS requirements (if applicable)
- Post-marketing commitment expectations
- Pediatric study requirements (PREA)
- Pregnancy registry needs
6. Review Pathway
- Priority Review eligibility
- Accelerated Approval considerations
- Real-Time Oncology Review (RTOR) for oncology products
- Assessment Aid usage
Topics to Avoid in Pre-NDA Meetings
Some topics are inappropriate for pre-NDA meeting discussion:
- Questions already addressed in FDA guidance documents
- Requests for FDA to design your studies
- Negotiations on approval requirements
- Topics unrelated to the specific NDA submission
- Issues that should have been resolved in earlier development meetings
Pre-NDA Meeting Package Preparation
Your pre-NDA meeting package submission determines meeting productivity. FDA reviewers have limited time to prepare; a well-organized package enables substantive responses.
Pre-NDA Meeting Package Timeline
| Action | Timing |
|---|---|
| Begin package preparation | 8 weeks before meeting request |
| Internal review and approval | 3-4 weeks before meeting request |
| Submit meeting request | 60+ days before target meeting date |
| Submit briefing document | 30 days before scheduled meeting |
| FDA preliminary responses | At least 2 calendar days before meeting |
| Meeting conducted | Scheduled date |
Briefing Document Structure
Your pre-NDA meeting briefing document should include:
Executive Summary (2-3 pages)
- Product overview
- Development program summary
- Key meeting objectives
- Critical questions list
Product Background (5-10 pages)
- Mechanism of action
- Therapeutic rationale
- Unmet medical need
- Development history
Efficacy Summary (10-20 pages)
- Pivotal trial designs
- Primary and secondary endpoints
- Key efficacy results
- Subgroup analyses
Safety Summary (10-20 pages)
- Safety database size and composition
- Common adverse events
- Serious adverse events
- Deaths and discontinuations
CMC Overview (5-10 pages)
- Manufacturing process summary
- Quality specifications
- Stability data overview
- Manufacturing site information
Regulatory Strategy (5-10 pages)
- Proposed indication
- Proposed labeling
- eCTD submission plan
- Review timeline expectations
Questions with Sponsor Positions (5-10 pages)
- Numbered questions organized by topic
- Sponsor position for each question
- Supporting rationale
- Attachments as needed
Keep your briefing document under 100 pages total. FDA reviewers appreciate concise, well-organized packages. Use attachments for detailed data that support your positions but aren't essential for every reviewer. The most productive pre-NDA meetings result from packages where every page is essential to answering a specific question-avoid creating comprehensive reference documents.
FDA Pre-NDA Meeting Timelines
Understanding PDUFA-mandated timelines helps you plan your pre-NDA meeting strategy and NDA submission timeline.
FDA Response and Scheduling Timelines
| Milestone | PDUFA Commitment |
|---|---|
| FDA response to meeting request | 21 calendar days |
| Pre-NDA meeting scheduling | Within 60 calendar days of request |
| Briefing document due | 30 days before meeting |
| FDA preliminary responses | At least 2 calendar days before meeting |
| Official meeting minutes | Within 30 days of meeting |
What If FDA Declines Your Meeting Request?
FDA may decline pre-NDA meeting requests if:
- Questions are unclear or lack sponsor positions
- The requested meeting type is inappropriate
- Issues can be addressed through written correspondence
- The sponsor hasn't provided sufficient background information
If declined, FDA will typically offer guidance on how to revise your request or suggest an alternative approach (such as written responses to specific questions).
If FDA declines your pre-NDA meeting request but offers written responses instead, treat those responses with the same weight as meeting minutes. Document the written responses in your regulatory file and ensure all team members understand the FDA guidance. These written responses are binding commitments, just as if they were discussed in person.
Pre-NDA Meeting Conduct: Best Practices
How you conduct the pre-NDA meeting affects the quality of FDA feedback and the binding nature of agreements reached.
Before the Pre-NDA Meeting
Preparation checklist:
- [ ] Review FDA preliminary responses thoroughly
- [ ] Prepare clarifying questions for ambiguous responses
- [ ] Assign speaking roles for each topic area
- [ ] Conduct internal dry run with subject matter experts
- [ ] Prepare backup slides for anticipated follow-up questions
- [ ] Confirm technology/logistics for virtual meetings
During the Pre-NDA Meeting
Meeting conduct principles:
- Begin with brief introductions (names and roles only)
- Confirm FDA has reviewed all materials
- Address questions in the order presented
- Take detailed notes of all FDA statements
- Ask for clarification on any ambiguous points
- Confirm key agreements before moving to next topic
- Reserve time at end for FDA questions
After the Pre-NDA Meeting
Post-meeting actions:
- Review draft meeting minutes carefully within 30 days
- Request revisions for any inaccuracies
- Document verbal agreements that may not appear in minutes
- Update NDA submission plan based on FDA feedback
- Brief cross-functional teams on commitments made
Common Pre-NDA Meeting Mistakes
Avoid these common errors that undermine pre-NDA meeting effectiveness:
Mistake 1: Requesting Too Early
Submitting a pre-NDA meeting request before Phase 3 data is available limits what FDA can address. Wait until you have substantive data to discuss.
Mistake 2: Vague Questions
Questions like "What does FDA think about our NDA?" generate unhelpful responses. Specific questions with clear sponsor positions get actionable feedback.
Mistake 3: Overwhelming Briefing Documents
Submitting 500-page briefing documents reduces FDA engagement. Focus on information essential for answering your specific questions.
Mistake 4: Ignoring Preliminary Responses
FDA's written preliminary responses often address your questions definitively. Sponsors who don't review these responses waste meeting time on already-answered questions.
Mistake 5: Poor Meeting Facilitation
Allowing discussions to go off-topic or failing to confirm agreements results in ambiguous meeting minutes. Designate a strong meeting facilitator.
Mistake 6: Introducing New Information
The pre-NDA meeting is not the time to present data FDA hasn't seen. New information should be submitted in advance for FDA review.
Pre-NDA Meeting for Expedited Programs
Sponsors with FDA expedited designations may have enhanced pre-NDA meeting opportunities.
Breakthrough Therapy Designation
Sponsors with Breakthrough Therapy Designation receive:
- More frequent Type B meetings throughout development
- Pre-BLA/Pre-NDA meeting with senior FDA leadership
- Intensive guidance on development program
- Discussion of potential expedited review options
Fast Track Designation
Fast Track products may request:
- More frequent meetings with FDA
- Rolling review discussions during pre-NDA meeting
- Pre-submission meeting focused on rolling review strategy
Priority Review Consideration
During your pre-NDA meeting, discuss Priority Review eligibility if your product:
- Treats a serious condition
- Provides significant improvement over existing treatments
- Addresses an unmet medical need
FDA cannot guarantee Priority Review designation before NDA submission, but pre-NDA meeting discussion can help you understand likelihood.
Key Takeaways
A pre-NDA meeting is a formal Type B meeting between a drug sponsor and FDA that occurs before submission of a New Drug Application. The meeting focuses on submission readiness, eCTD format, clinical data presentation, labeling, and any outstanding scientific questions. FDA must schedule pre-NDA meetings within 60 calendar days of receiving the meeting request.
Key Takeaways
- Pre-NDA meetings are Type B meetings that must be scheduled within 60 calendar days of request, providing critical alignment before NDA submission
- Request timing matters - submit your meeting request 5-7 months before your planned NDA submission with complete Phase 3 data available
- Specific questions get specific answers - every pre-NDA meeting question should include your proposed approach and request FDA agreement
- Briefing documents should be comprehensive but concise - aim for under 100 pages with clear organization and supporting attachments
- Meeting minutes are binding - review carefully, request corrections within 30 days, and ensure all agreements are documented
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Next Steps
A successful pre-NDA meeting sets the foundation for a smooth NDA review. But even with FDA alignment on strategy, submission execution matters. Formatting errors, eCTD validation failures, and document inconsistencies can trigger refuse-to-file decisions regardless of your clinical data quality.
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
Sources
- FDA Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
- 21 CFR Part 312 - Investigational New Drug Application
- PDUFA VII Commitment Letter - FDA Performance Goals
- FDA Guidance for Industry: Content and Format of INDs for Phase 1 Studies