Pre-IND Meeting: Complete FDA Preparation Guide for Drug Developers
A pre-IND meeting is a formal Type B regulatory meeting with the FDA scheduled within 60 days of your request that allows sponsors to present proposed clinical development plans, nonclinical strategies, and manufacturing approaches before submitting an IND application. These meetings provide documented FDA feedback that can prevent costly clinical holds and streamline the development pathway-sponsors with pre-IND meetings experience approximately 30% fewer initial clinical holds than those submitting INDs without prior FDA engagement.
A pre-IND meeting is a formal Type B meeting between a drug sponsor and the FDA that occurs before submitting an Investigational New Drug (IND) application. This meeting allows sponsors to present their drug development plans and receive documented FDA feedback on proposed clinical trial designs, nonclinical study packages, manufacturing processes, and regulatory strategy before committing significant resources to IND-enabling activities.
For biotech and pharmaceutical companies, the pre-IND meeting represents one of the most valuable regulatory interactions in the entire drug development process. A well-prepared pre-IND meeting can save 6-12 months of development time and millions of dollars by identifying potential clinical holds before they occur.
In this guide, you will learn:
- How to request and prepare for a pre-IND meeting with FDA
- What to include in your pre-IND briefing document for maximum impact
- The specific questions that generate actionable FDA feedback
- Common pre-IND meeting mistakes and strategies to avoid them
- How expedited programs affect your pre-IND meeting approach
What Is a Pre-IND Meeting?
A pre-IND meeting is a formal Type B regulatory meeting under FDA guidance where sponsors present their proposed Investigational New Drug (IND) development program and receive documented FDA feedback on clinical trial design, nonclinical study strategy, manufacturing processes, and regulatory pathway before submitting the IND application.
A pre-IND meeting is a formal regulatory meeting classified as a Type B meeting under FDA's formal meeting guidance. The purpose is to discuss investigational new drug application requirements and obtain FDA input on proposed development plans before the sponsor commits to a specific clinical development strategy.
Key characteristics of a pre-IND meeting:
- Classified as a Type B meeting with 60-day scheduling requirement per PDUFA VII
- Written FDA responses provided no later than 5 calendar days before the scheduled meeting
- Focuses on IND content requirements, Phase 1 clinical trial design, and nonclinical study adequacy
- Non-binding but provides documented FDA position that guides development decisions
- No user fee required for meeting request
According to FDA PDUFA VII commitments, the agency must schedule Type B meetings, including pre-IND meetings, within 60 calendar days of receiving the meeting request. FDA preliminary responses must be provided no later than 5 calendar days before the scheduled meeting date.
The pre-IND meeting is particularly valuable because it occurs at a decision point where sponsor investment is still relatively limited. Most sponsors have not yet finalized their IND-enabling toxicology studies when they request a pre-IND meeting. Obtaining FDA alignment early can prevent costly pivots and repeat studies during clinical development.
Schedule your pre-IND meeting after completing exploratory toxicology and pharmacology studies but before initiating expensive GLP IND-enabling studies. This timing maximizes FDA's ability to influence your study designs while minimizing the cost of modifications based on their feedback. Many experienced sponsors conduct a Type C pre-Type B meeting if they're uncertain about optimal timing.
Why Timing Matters for Pre-IND Meetings:
The difference between requesting your pre-IND meeting too early versus at the optimal window can significantly impact the meeting's value. Request too early and FDA may suggest you gather more data first; request too late and your development decisions become locked in, making FDA feedback expensive to implement. The sweet spot is having enough data to propose a specific clinical plan but enough flexibility to modify nonclinical studies based on FDA input.
Pre-IND Meeting vs. Other FDA Meeting Types
Understanding where the pre-IND meeting fits in the FDA meeting framework helps sponsors time their requests appropriately.
| Meeting Type | Classification | Scheduling Timeline | Purpose |
|---|---|---|---|
| Pre-IND meeting | Type B | 60 days | Discuss IND requirements before submission |
| Type A meeting | Type A | 30 days | Urgent issues (clinical holds, safety) |
| End of Phase 2 meeting | Type B | 60 days | Phase 3 design and endpoints |
| Pre-NDA/Pre-BLA meeting | Type B | 60 days | Marketing application requirements |
| Type C meeting | Type C | 75 days | Other development questions |
The pre-IND meeting belongs to the Type B category, which covers critical development milestones. Unlike Type A meetings (reserved for urgent situations like clinical holds), pre-IND meetings are planned interactions that occur when sponsors have sufficient data to propose a clinical development program.
Pre-IND Meeting FDA: When to Request One
A pre-IND meeting FDA request should be timed strategically in your development program. Requesting too early wastes the regulatory opportunity; requesting too late means critical decisions are already locked in and expensive to change.
Optimal Timing for a Pre-IND Meeting
| Development Stage | Pre-IND Meeting Appropriateness | Rationale |
|---|---|---|
| Discovery/early preclinical | Too early | Insufficient data to discuss meaningfully |
| Lead optimization complete | Consider timing | May have enough data for initial questions |
| IND-enabling studies planned | Optimal window | Can influence study design before commitment |
| IND-enabling studies underway | Acceptable | Some flexibility remains for modifications |
| IND-enabling studies completed | Late but still valuable | Data available but changes are costly |
| IND already submitted | Too late | Should have requested meeting earlier |
The optimal window for requesting a pre-IND meeting is when you have completed sufficient preclinical pharmacology and exploratory toxicology to propose a specific clinical development plan, but before you have initiated GLP IND-enabling toxicology studies that would be costly to modify based on FDA feedback.
Situations Where Pre-IND Meetings Are Critical
A pre-IND meeting becomes essential when your development program involves:
- Novel mechanism of action - FDA may have specific safety concerns or pharmacology requirements not addressed in existing guidance
- First-in-class compound - No regulatory precedent exists to follow for development pathway
- Complex manufacturing - Cell therapies, gene therapies, and biologics with novel manufacturing processes warrant CMC discussions
- Pediatric-only indication - Unique considerations for pediatric study design and formulation
- Rare disease/orphan indication - Opportunity to discuss expedited program eligibility and flexible endpoints
- Combination products - Jurisdictional questions and regulatory pathway clarification needed
- Repurposed or reformulated drugs - 505(b)(2) pathway questions and bridging study requirements
- Novel endpoints - Biomarker-based or surrogate endpoints require FDA alignment
FDA data shows that sponsors who hold pre-IND meetings experience approximately 30% fewer clinical holds on their initial IND submissions compared to sponsors who submit INDs without prior FDA engagement.
When a Pre-IND Meeting May Not Be Necessary
Some sponsors choose to proceed directly to IND submission without a pre-IND meeting when:
- The product follows a well-established development pathway with clear FDA precedent
- Previous FDA interactions (such as a Type C meeting) have addressed key development questions
- The sponsor has extensive experience with highly similar products in the same therapeutic area
- Time pressure makes the 60-day meeting timeline impractical for competitive or strategic reasons
- The indication and molecule type have extensive FDA guidance documents covering requirements
However, even experienced sponsors often find pre-IND meetings valuable for validating assumptions and creating a documented record of FDA concurrence with their development approach.
IND Meeting Request: The Step-by-Step Process
Requesting an IND meeting requires following FDA's formal meeting request procedures outlined in the agency's formal meetings guidance. Understanding these steps ensures your request is processed efficiently and accepted.
Step 1: Prepare the Meeting Request Letter
Your formal meeting request letter must include all required elements for FDA to grant the meeting:
| Required Element | Description | Tips for Success |
|---|---|---|
| Product name | INN or company designation | Use consistent naming throughout |
| Application type | Pre-IND meeting request | Clearly state "Pre-IND Meeting" |
| Meeting type | Type B meeting | Reference PDUFA meeting categories |
| Proposed meeting dates | 3 date/time options within scheduling window | Offer flexibility across 2-3 weeks |
| Meeting format | In-person, teleconference, or written response only | Teleconference is most common |
| Preliminary list of questions | Specific questions for FDA | Number questions clearly |
| List of attendees | Sponsor representatives who will participate | Include titles and roles |
| Brief product summary | 1-2 paragraph overview | Mechanism, indication, development stage |
Step 2: Submit to Appropriate FDA Division
Submit your meeting request to the CDER or CBER division responsible for your product type:
CDER Submissions (small molecules, most biologics):
- Office of New Drugs review divisions based on therapeutic area
- Office of Pharmaceutical Quality for CMC-focused meetings
- Use the CDER Document Room or electronic submission
CBER Submissions (cell/gene therapies, vaccines, blood products):
- Office of Tissues and Advanced Therapies (OTAT) for cell and gene therapies
- Office of Vaccines Research and Review for vaccines
- Office of Blood Research and Review for blood products
Combination Products:
- Submit to the division with primary jurisdiction based on primary mode of action
- Consider requesting a pre-RFD meeting if jurisdiction is unclear
FDA must respond to Type B meeting requests within 21 calendar days to confirm whether the meeting is granted and provide the confirmed meeting date and format.
Contact your target review division informally before submitting the formal meeting request letter. A brief call with the division chief or appropriate reviewer can confirm the best submission format, clarify which division has jurisdiction, and identify any preliminary concerns. This informal pre-submission guidance prevents meeting request denials due to scope or procedural issues.
Step 3: Receive FDA Response
Within 21 calendar days of your meeting request submission, FDA will respond with:
- Meeting granted or denied status with rationale if denied
- Confirmed meeting date (within 60 days of original request)
- Meeting format (in-person at FDA campus, teleconference, or written response only)
- Preliminary feedback on the proposed agenda or questions
- Instructions for briefing document submission
If FDA denies your meeting request, the response will explain why. Common denial reasons include insufficient product development to warrant a meeting, questions that can be answered through written correspondence, or requests that are outside the scope of a pre-IND meeting.
Step 4: Submit the Briefing Document
Once FDA confirms your meeting, you must submit a comprehensive briefing document according to specific timelines:
| Milestone | Timeline | Notes |
|---|---|---|
| Meeting request submitted | Day 0 | Start of the process |
| FDA confirms meeting | Within 21 days | Receive date, format confirmation |
| Briefing document due | 30 days before meeting | FIRM deadline - late submissions may result in rescheduling |
| FDA preliminary responses | 5 calendar days before meeting | Written FDA position on your questions |
| Meeting conducted | Within 60 days of original request | Per PDUFA VII commitment |
| Official meeting minutes | 30 days after meeting | FDA issues official meeting minutes |
FDA Pre-IND Briefing Document: What to Include
The FDA pre-IND briefing document is the foundation of a successful meeting. This document should present your development program clearly, provide sufficient data for FDA to evaluate your proposals, and frame specific questions that generate actionable regulatory feedback.
Required Briefing Document Sections
1. Executive Summary (1-2 pages)
- Brief product description and proposed indication
- Key questions organized by topic area
- Summary of sponsor's proposed development approach
2. Product Description (3-5 pages)
- Drug substance and drug product description
- Mechanism of action with supporting data
- Proposed indication and target patient population
- Pharmacological rationale for the indication
3. Nonclinical Summary (10-15 pages)
- Pharmacology studies completed and summary findings
- Exploratory toxicology data available
- Proposed IND-enabling toxicology study design
- Pharmacokinetics/ADME data and human PK predictions
- Species selection rationale for toxicology studies
4. Clinical Development Plan (10-15 pages)
- Proposed Phase 1 study design and objectives
- First-in-human dose selection rationale with calculations
- Dose escalation scheme with decision rules
- Safety monitoring plan and stopping rules
- Preliminary Phase 2/3 development strategy
- Target product profile
5. Chemistry, Manufacturing, and Controls (5-10 pages)
- Drug substance manufacturing process overview
- Drug product formulation and manufacturing
- Analytical methods and proposed specifications
- Stability data available and proposed studies
- GMP compliance status
6. Regulatory Strategy (2-3 pages)
- Proposed regulatory pathway (NDA, BLA, 505(b)(2))
- Expedited program considerations (Breakthrough Therapy, Fast Track, Orphan Drug, RMAT)
- Global development strategy if applicable
- Special protocol assessment considerations
7. Questions for FDA (2-5 pages)
- Numbered questions organized by topic
- Background context provided for each question
- Sponsor's proposed approach or position stated clearly
- Specific yes/no or either/or format when possible
Briefing Document Best Practices
| Best Practice | Rationale |
|---|---|
| Limit main document to 50-70 pages | FDA reviewers have limited time; focused documents get better responses |
| Include clear executive summary | Ensures reviewers understand key issues even if time-constrained |
| Organize questions by discipline | Allows appropriate FDA reviewers to prepare for their areas |
| State sponsor position for each question | FDA responds better to specific proposals than open-ended requests |
| Use appendices for detailed data | Keep main document focused while providing supporting information |
| Number all pages and sections | Facilitates reference during meeting discussion |
| Include clear figures and tables | Visual presentation improves comprehension |
Your executive summary is the most important section of the entire briefing document. FDA reviewers may skim the full document but will carefully read your executive summary. Spend significant time crafting a summary that clearly articulates your three to five most important questions and why FDA feedback matters for your development program. A strong executive summary can be the difference between receiving thoughtful, detailed FDA responses and generic, superficial ones.
Briefing Document Common Mistakes
| Mistake | Consequence | Solution |
|---|---|---|
| Submitting late | Meeting rescheduled or cancelled | Build in buffer time for internal review |
| Too much raw data | Key messages lost in detail | Summarize data in main document; appendix for details |
| Vague questions | Vague FDA responses | Use specific yes/no or either/or question formats |
| Missing sponsor position | FDA cannot agree or disagree | Always state what you propose before asking the question |
| Excessive questions | Superficial responses to all | Limit to 10-15 focused, prioritized questions |
Investigational New Drug Meeting: Key Questions to Ask
Your investigational new drug meeting success depends largely on asking the right questions. Poorly framed questions waste the regulatory opportunity; well-crafted questions generate actionable FDA feedback that guides your development program.
High-Value Pre-IND Meeting Questions by Category
Clinical Development Questions:
- Does FDA agree with the proposed Phase 1 study design, including patient population, study duration, and key endpoints?
- Is the proposed starting dose adequately justified by the nonclinical data, and does FDA agree with the dose selection methodology?
- Are the proposed safety monitoring procedures and stopping rules appropriate for this mechanism of action?
- Does FDA have concerns about the dose escalation scheme, including the proposed dose increments and maximum dose?
- Is the proposed patient population appropriate for first-in-human studies, and does FDA agree with the inclusion/exclusion criteria?
Nonclinical Questions:
- Are the proposed IND-enabling toxicology studies adequate to support the planned Phase 1 clinical trial design and duration?
- Is the proposed duration of repeat-dose toxicology studies appropriate for the planned clinical trial duration?
- Does FDA agree with the species selection for toxicology studies given the mechanism of action and available data?
- Are additional pharmacology studies needed before IND submission to characterize on-target or off-target effects?
- Does FDA agree with the proposed approach to genotoxicity testing for this compound class?
CMC Questions:
- Is the proposed drug substance specification adequate to support Phase 1 clinical trials?
- Does FDA agree with the proposed comparability approach for anticipated manufacturing changes during development?
- Are the proposed stability protocols adequate to support the planned clinical trial supply chain?
- Is the proposed container closure system acceptable for the intended Phase 1 formulation?
- Does FDA have concerns about the proposed analytical methods for release and stability testing?
Regulatory Strategy Questions:
- Based on the data presented, does the product potentially qualify for expedited programs such as Breakthrough Therapy, Fast Track, or Orphan Drug Designation?
- Does FDA agree with the proposed regulatory pathway (NDA vs. BLA, or 505(b)(2)) for this product?
- Are there specific requirements for this product type that should be addressed in the IND based on recent guidance or precedent?
- Does FDA agree with the proposed Phase 2/3 development strategy and preliminary endpoints?
Question Formatting Best Practices
Structure each question using this format for maximum FDA engagement:
Example of Well-Formatted Question:
“Question 4: Starting Dose Selection
“
“Background: Based on the completed GLP-compliant toxicology studies in rats and dogs, the NOAEL was determined to be 50 mg/kg in rats and 25 mg/kg in dogs. Using FDA-recommended allometric scaling and a safety factor of 10, we calculate a maximum recommended starting dose (MRSD) of 5 mg in humans.
“
“Sponsor Position: We propose a starting dose of 2 mg, which represents 40% of the MRSD, to provide an additional safety margin for this first-in-human study given the novel mechanism of action.
“
“Question: Does FDA agree that a starting dose of 2 mg is appropriate for the proposed Phase 1 study?
This format provides FDA reviewers with the context they need to evaluate your proposal and respond with a clear agreement, disagreement, or alternative recommendation.
Pre-IND Meeting Preparation Timeline
Successful pre-IND meeting preparation requires advance planning across regulatory, clinical, nonclinical, and CMC teams. This timeline ensures adequate preparation time for a high-quality meeting.
20-Week Comprehensive Preparation Timeline
| Weeks Before Meeting | Activity | Responsible Team |
|---|---|---|
| Week 20-18 | Define meeting objectives and draft preliminary questions | Regulatory Affairs |
| Week 18-16 | Gather nonclinical data and draft nonclinical sections | Nonclinical/Toxicology |
| Week 16-14 | Draft clinical development plan and Phase 1 protocol synopsis | Clinical Development |
| Week 14-12 | Compile CMC information and draft CMC sections | CMC/Quality |
| Week 12-10 | Integrate all sections and conduct cross-functional review | All teams |
| Week 10-8 | Finalize and submit meeting request to FDA | Regulatory Affairs |
| Week 8-6 | Receive FDA meeting confirmation (within 21 days) | FDA |
| Week 6-5 | Address any FDA feedback on meeting scope | Regulatory Affairs |
| Week 5-4 | Final briefing document review and approval | Leadership/All teams |
| Week 4 | Submit briefing document (30 days before meeting) | Regulatory Affairs |
| Week 3-2 | Prepare presentation materials and backup slides | All teams |
| Week 2-1 | Conduct internal dry runs and rehearsals | All teams |
| Day -2 | Receive FDA preliminary responses | FDA |
| Day -1 | Review FDA responses and prepare follow-up questions | All teams |
| Meeting Day | Conduct pre-IND meeting | Sponsor team |
| Week +1-4 | Review and approve FDA meeting minutes | Regulatory Affairs |
Internal Preparation Checklist
Before the meeting date, ensure your team has completed these critical preparation activities:
- [ ] Rehearsed responses to likely FDA questions and challenges
- [ ] Prepared backup slides for detailed technical questions in each discipline
- [ ] Identified lead responders for each topic area (clinical, nonclinical, CMC, regulatory)
- [ ] Thoroughly reviewed FDA preliminary responses and prepared follow-up questions
- [ ] Confirmed all attendees, their roles, and speaking assignments
- [ ] Tested technology if teleconference format (audio, screen sharing, backup options)
- [ ] Prepared contingency positions if FDA disagrees with primary proposals
- [ ] Briefed executive leadership on key issues and potential outcomes
- [ ] Assigned dedicated note-taker for capturing FDA verbal comments
The FDA will send preliminary written responses to your briefing document questions no later than 5 calendar days before your meeting. Do not wait until these responses arrive to begin rehearsing-prepare responses to the likely FDA challenges and questions your team anticipates. When FDA's written responses arrive, incorporate them into your final rehearsal to refine your discussion approach. This front-loaded preparation ensures your team can engage substantively when FDA raises unexpected points during the actual meeting.
Pre-IND Meeting Format Comparison
FDA offers three formats for pre-IND meetings. Understanding the differences helps you request the most appropriate format for your situation.
Meeting Format Comparison Table
| Feature | In-Person Meeting | Teleconference | Written Response Only |
|---|---|---|---|
| Real-time discussion | Yes | Yes | No |
| Follow-up questions | Yes, immediate | Yes, immediate | Limited or none |
| FDA body language/tone | Visible | Audio cues only | None |
| Travel required | Yes (White Oak campus) | No | No |
| Scheduling flexibility | Lowest | Moderate | Highest |
| Documentation | Official meeting minutes | Official meeting minutes | Written response document |
| Best suited for | Complex scientific discussions | Standard development questions | Straightforward confirmatory questions |
| Typical duration | 60-90 minutes | 60 minutes | N/A |
When to Request Each Format
Request In-Person Meeting When:
- Novel mechanism requires detailed scientific discussion with diagrams or visual aids
- Complex manufacturing questions benefit from showing process flow diagrams
- Multiple FDA divisions are involved and coordination is needed
- You want to establish a relationship with the review team for ongoing development
- The program has strategic importance warranting maximum engagement
Request Teleconference When:
- Questions are moderately complex but do not require visual presentation
- In-person meeting is not logistically feasible due to timeline or travel constraints
- FDA has indicated teleconference is their preference for this meeting type
- The development program is relatively straightforward with clear precedent
Request Written Response Only When:
- Questions are straightforward with clear yes/no or either/or answers
- Time pressure makes waiting for a scheduled meeting impractical
- You have limited questions (fewer than 5) that do not require interactive discussion
- Previous FDA interactions have addressed most development questions
According to FDA meeting statistics, approximately 75% of Type B meetings are now conducted via teleconference, with written response only format becoming more common following the shift to remote work practices after 2020.
Common Pre-IND Meeting Mistakes to Avoid
Avoiding these common errors maximizes your pre-IND meeting value and ensures you receive actionable FDA feedback.
Mistake 1: Asking the Wrong Types of Questions
| Poor Question | Better Question | Why It Matters |
|---|---|---|
| "What studies do we need?" | "Does FDA agree that the proposed toxicology package supports the Phase 1 trial design?" | FDA provides input on your proposals, not designs your program |
| "Is this okay?" | "Does FDA have concerns about the proposed starting dose of 2 mg based on the nonclinical data?" | Specific questions get specific, actionable answers |
| "What does FDA recommend?" | "Does FDA agree with our proposed approach to X, or does FDA recommend alternative approach Y?" | Framing options shows preparation and enables clear FDA response |
| "Any other comments?" | "Are there additional safety considerations FDA recommends addressing in the Phase 1 protocol?" | Focused follow-up questions generate more useful responses |
Mistake 2: Insufficient Briefing Document Detail
FDA cannot provide meaningful responses without adequate context. Common gaps that undermine meeting value include:
- Missing nonclinical study summaries and data tables
- Vague clinical development plans without specific protocol elements
- Insufficient CMC information to evaluate manufacturing adequacy
- Questions without sponsor position preventing FDA from agreeing or disagreeing
- Missing dose selection calculations and safety factor rationale
- Incomplete regulatory history for previously developed compounds
Mistake 3: Too Many Questions
The optimal pre-IND meeting briefing document contains 10-15 focused questions. Excessive questions create problems:
- Dilute FDA attention across too many topics
- Result in superficial responses that lack actionable detail
- Suggest the sponsor has not prioritized critical development decisions
- May cause FDA to suggest reducing scope or scheduling additional meetings
- Overwhelm the meeting time available for discussion
Mistake 4: Treating FDA Feedback as Optional
Pre-IND meeting feedback, while technically non-binding, represents FDA's documented position on your development program. Ignoring this feedback can result in:
- Clinical holds on IND submission for issues previously raised
- Repeated review cycles and Refuse to File actions on marketing applications
- Delays in overall development program timeline
- Damaged relationship with review division affecting future interactions
- Increased scrutiny on subsequent submissions
Mistake 5: Poor Follow-Up Documentation
After the meeting, sponsors should take these critical follow-up actions:
- Request official meeting minutes from FDA within the 30-day issuance window
- Document any verbal agreements or commitments made during the meeting
- Clarify any ambiguous responses through written correspondence if needed
- Update internal development plans based on FDA feedback
- Share meeting outcomes across all relevant functional teams
- File meeting minutes and correspondence for regulatory history
Expedited Programs and Pre-IND Meetings
For programs that may qualify for FDA expedited development programs, the pre-IND meeting provides an important opportunity to discuss eligibility and implications.
Expedited Program Eligibility Discussion
| Program | Discussion Topic for Pre-IND Meeting |
|---|---|
| Breakthrough Therapy Designation | Whether preliminary clinical evidence supports substantial improvement over existing therapies |
| Fast Track Designation | Whether product addresses serious condition and demonstrates potential to address unmet need |
| Orphan Drug Designation | Whether prevalence data supports orphan indication; development incentives |
| Regenerative Medicine Advanced Therapy (RMAT) | Whether product meets RMAT criteria; expedited development pathway options |
| Accelerated Approval | Whether surrogate or intermediate endpoints could support accelerated approval |
Sponsors with Breakthrough Therapy Designation receive intensive FDA guidance including more frequent meetings, organizational commitment involving senior managers, and eligibility for rolling review of their marketing application.
If your product may qualify for an expedited program, explicitly ask about it in your pre-IND meeting questions. FDA can provide guidance on which designations your product might support and what evidence would be needed to pursue them. Many sponsors miss expedited program opportunities because they don't raise the question early enough in development.
Pre-IND Meeting Questions for Expedited Programs
Consider including these questions if expedited programs may apply to your development:
- Based on the mechanism of action and preclinical data, does FDA agree that this product may qualify for Breakthrough Therapy Designation upon demonstration of preliminary clinical evidence?
- Does FDA agree that the proposed indication addresses a serious or life-threatening condition with unmet medical need that could support Fast Track Designation?
- What clinical evidence would FDA consider sufficient to support a Breakthrough Therapy Designation request following Phase 1?
- Does FDA agree that the proposed surrogate endpoint could potentially support Accelerated Approval for this indication?
Key Takeaways
A pre-IND meeting is a formal Type B meeting between a drug sponsor and the FDA that occurs before submitting an Investigational New Drug (IND) application. The meeting allows sponsors to discuss proposed clinical development plans, nonclinical strategy, CMC approaches, and regulatory pathway with FDA reviewers and receive documented feedback before committing resources to IND-enabling activities. Pre-IND meetings are classified as Type B meetings under FDA formal meeting guidance with 60-day scheduling requirements.
Key Takeaways
- Pre-IND meetings are Type B meetings with 60-day scheduling timelines and 30-day briefing document submission requirements under PDUFA VII
- Optimal timing for requesting a pre-IND meeting is after completing sufficient preclinical work to propose a clinical plan but before initiating costly GLP IND-enabling toxicology studies
- Question quality determines meeting value - frame specific questions with context, sponsor position, and clear yes/no or either/or format for actionable FDA responses
- Briefing documents should be 50-70 pages with an executive summary, complete development plan, and 10-15 numbered questions organized by discipline
- Expedited program eligibility should be discussed at the pre-IND meeting when the product may qualify for Breakthrough Therapy, Fast Track, or other designations
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Next Steps
Preparing for a pre-IND meeting requires coordinating regulatory, clinical, nonclinical, and CMC teams to develop a comprehensive briefing document and focused question strategy. The investment in thorough preparation pays dividends throughout the drug development process by preventing costly pivots and clinical holds.
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 Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics - Chemistry, Manufacturing, and Controls Information
- PDUFA VII Commitment Letter - FDA Meeting Management Goals
- 21 CFR Part 312 - Investigational New Drug Application