INTERACT vs Pre-IND Meeting: Which FDA Meeting to Request
The first conversation a sponsor has with the FDA often sets the trajectory for everything that follows. INTERACT is more of a “blue-sky” meeting and typically takes place before a Pre-IND meeting. The two serve different purposes, so it is not accurate to describe this as “requesting the wrong meeting.”
Pre-IND meetings are much more widely recognized by sponsors than INTERACT meetings, which often leads to the misconception that Pre-IND should be the first interaction with the Agency. In many cases, however, an INTERACT meeting can be far more efficient and valuable as an earlier opportunity to align with FDA on the broader development strategy before the sponsor invests heavily in clinical trial preparation, which a Pre-IND Meeting requires.
The main purpose of this article is to educate sponsors on the distinction between INTERACT and Pre-IND meetings, and more importantly, to highlight that there is an opportunity to engage with the FDA very early in drug development.
Only Orphans Cote works with sponsors across every FDA meeting type, including INTERACT, Pre-IND, and Type A, B, C, and D meetings. Led by Dr. Timothy Cote, former Director of the FDA Office of Orphan Products Development (OOPD), with a staff that includes a former FDA OOPD reviewer, our team helps sponsors prepare, present, and follow through so each interaction with the agency moves the program forward. This article explains how INTERACT and Pre-IND meetings differ and how to decide which one your program is ready for.
What Is the Difference Between an INTERACT and a Pre-IND Meeting?
An INTERACT meeting is an early FDA discussion for sponsors who have identified their investigational product and completed some preliminary preclinical proof-of-concept studies but have not yet designed or conducted definitive toxicology studies. A Pre-IND meeting is a Type B meeting for sponsors who have defined their manufacturing process and are ready to discuss IND-enabling studies and first-in-human trial design.
The dividing line is definitive toxicology studies. If you have not designed them yet, INTERACT is the meeting that fits. If you have completed proof-of-concept work and are moving toward definitive toxicology, the program has advanced past INTERACT and into Pre-IND territory.
INTERACT is one of six formal meeting types under the Prescription Drug User Fee Act, alongside Type A, Type B, Type B (end of phase), Type C, and Type D meetings. It covers products regulated by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
What Is an FDA INTERACT Meeting?
INTERACT stands for INitial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs. We describe it as the "blue sky" meeting: an early conversation that clarifies FDA requirements and helps sponsors avoid delays when planning first-in-human studies.
An INTERACT meeting fits when a sponsor has identified the investigational product to be evaluated in a clinical study and has conducted some preliminary preclinical proof-of-concept studies with that intended product, but has not yet designed and conducted definitive toxicology studies.
An INTERACT meeting can be valuable in several circumstances when a sponsor has focused questions about preclinical efficacy, safety, pharmacology, or other early development issues before a first-in-human study.
One of the key distinctions is that an INTERACT meeting does not require the same level of maturity or comprehensiveness across development disciplines as a Pre-IND meeting. Sponsors may seek targeted FDA feedback on specific early questions even while other areas of the program are still evolving. This makes INTERACT particularly useful for resolving important issues before committing substantial time and resources to a more complete Pre-IND package and subsequent clinical development activities.
Per OTP's published procedures:
- The meeting package must be submitted with the meeting request, not later.
- OTP responds with a decision to grant or deny by Day 21.
- If granted, the meeting is held within 75 calendar days of receipt of the request.
- Meetings are scheduled for 60 minutes.
- The package should not exceed 50 pages.
- A maximum of 10 questions is considered reasonable, and sub-questions count toward that total.
- OTP sends preliminary responses no later than 5 days before the meeting.
- The sponsor responds to those preliminary responses no later than 3 days before the meeting.
Two procedural points catch sponsors off guard. And questions about definitive preclinical safety studies belong in the Pre-IND meeting, not the INTERACT package.
Why INTERACT Requests Get Denied
OTP publishes its reasons for denying INTERACT requests, and most are avoidable:
- A meeting was already held for the product.
- No meeting package accompanied the request.
- The package was substantially deficient, limiting FDA's ability to give constructive feedback.
- The questions concerned jurisdiction or regulatory pathway, which INTERACT does not address.
- The program stage was premature, meaning the sponsor had not specified the investigational product or had not conducted preclinical proof-of-concept studies with it.
- The program stage was too advanced, meaning proof-of-concept and some safety studies were complete, the manufacturing process was defined with assays and preliminary lot release criteria developed, the platform matched other products the sponsor had already submitted, or clinical data already existed for the same product and indication.
What Is an FDA Pre-IND Meeting?
A Pre-IND meeting is a Type B meeting held before an IND application is submitted. Its primary purpose is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and the product manufacturing and quality controls needed to initiate human studies. It can also cover plans for studying the product in pediatric populations, the target product profile, the quality target product profile, the design and results of any natural history studies, and how best to present and format data in the IND.
For rare disease programs, the natural history discussion carries particular weight, and a well-run Pre-IND meeting reduces the risk of a clinical hold once the IND is filed.
A Pre-IND is the appropriate meeting type when:
- The manufacturing process for the clinical studies is defined, with assays and preliminary lot release criteria developed.
- Proof-of-concept work is complete, possibly along with some preliminary preclinical safety or toxicology studies, and the sponsor is moving toward definitive toxicology studies.
- The questions involve IND-enabling chemistry, manufacturing, and controls (CMC), pharmacology and toxicology, or clinical trial design.
Per OTP's published procedures, OTP responds to the request by Day 21 and schedules the meeting within 60 days. The meeting package is due at least 30 days before the meeting date, packages typically run 50 to 100 pages, and OTP will not commit to reviewing packages beyond 250 to 300 pages. Preliminary responses arrive no later than 2 days before the meeting, and the sponsor responds no later than 24 hours before. Unlike INTERACT, OTP issues a meeting summary within 30 calendar days, and OTP's version is the official record.
One constraint deserves emphasis: OTP grants one Pre-IND meeting per product and clinical indication. A second Pre-IND will not be held to pre-review an IND submission. OTP also declines requests that cover only a single discipline or that signal an intent to hold separate discipline-specific meetings, because CMC, pharmacology and toxicology, and clinical review are interdependent early in development.
INTERACT vs Pre-IND: Side-by-Side Comparison
| Feature | INTERACT Meeting | Pre-IND Meeting (Type B) |
|---|---|---|
| Stage of development | Preliminary preclinical proof-of-concept complete; definitive toxicology studies not yet designed | Manufacturing process defined; proof-of-concept complete; moving toward definitive toxicology |
| Primary purpose | Early advice on novel or complex development questions | Feedback on preclinical study design, initial IND study design, and manufacturing and quality controls |
| Meeting package timing | Submitted with the meeting request | At least 30 days before the meeting |
| FDA response to request | By Day 21 | By Day 21 |
| Meeting held within | 75 days of request receipt | 60 days of request receipt |
| Package length | Not to exceed 50 pages | Typically 50 to 100 pages |
| Maximum questions | 10, including sub-questions | 10, including sub-questions |
| Preliminary responses | No later than 5 days before | No later than 2 days before |
| Meeting summary | Not issued; preliminary responses annotated and resent within 30 days if advice changes | Issued within 30 calendar days; OTP's version is official |
| Repeat meetings | Denied if a meeting was already held for the product | One per product and clinical indication |
| Definitive toxicology questions | Not appropriate; reserve for Pre-IND | Appropriate |
Sources: FDA OTP INTERACT Meetings; FDA OTP Pre-IND Meetings; SOPP 8101.1; PDUFA VII performance goals.
How to Choose Between INTERACT and Pre-IND
Work through these questions in order:
- Have you identified the specific investigational product that will go into the clinic? If not, both meetings are premature. FDA denies INTERACT requests where the sponsor has not specified the product.
- Have you generated preclinical proof-of-concept data with that exact product? If not, an INTERACT request will likely be denied as premature.
- Have you designed your definitive toxicology studies? If no, INTERACT fits. If yes, the program has moved past INTERACT.
- Is your manufacturing process defined, with assays and preliminary lot release criteria in place? If yes, request a Pre-IND meeting.
- Are your questions about IND-enabling CMC, pharmacology and toxicology, or clinical trial design? If yes, those questions belong in a Pre-IND package.
- Have you already held a meeting for this product? If yes, an INTERACT request will be denied, and OTP grants only one Pre-IND per product and indication.
Programs using a platform the sponsor has already submitted to FDA, or products with existing clinical data for the same indication, are treated as too advanced for INTERACT even if the sponsor feels early.
Common Misconceptions
- INTERACT is not an informal chat: The meeting requires a complete package submitted alongside the request. A package that arrives late or arrives deficient is a documented reason for denial.
- INTERACT is not a forum for exploring options: FDA gives feedback on a proposed program. Questions about which of several approaches to take, or about jurisdiction and regulatory pathway, fall outside the scope. Jurisdiction questions are directed elsewhere within the agency.
- An INTERACT meeting does not replace a Pre-IND meeting: They sit at different stages. Definitive preclinical safety study questions are explicitly reserved for the Pre-IND.
- Meeting outcomes are not recorded the same way: Sponsors who expect a formal summary after an INTERACT meeting will not receive one.
- A denied request is not a dead end: FDA may advise that a program is too early for the interaction, or may change the meeting format to a Pre-IND or Type C meeting where the sponsor's focus is clinical development. However, talk to Only Orphans Cote to determine the most appropriate FDA meeting format for your program and help avoid unnecessary delays. Request a meeting today.
Working With Only Orphans Cote on FDA Meetings
Meetings with the FDA are critical checkpoints in orphan drug designation, from early-stage advice to resolving urgent regulatory challenges. Only Orphans Cote's FDA meeting support covers:
- FDA Meeting Strategy & Format Assessment
- Drafting and refining FDA meeting requests and briefing packets.
- Ensuring all materials comply with FDA guidance and expectations.
- Coordinating subject matter experts for technical accuracy.
- Moderating FDA meetings, virtually or on-site in Maryland, USA.
Our team has experience across every meeting type, including INTERACT, Pre-IND, and Type A, B, C, and D. Because the package is the conversation, most of the value is created before the meeting is ever scheduled.
Sponsors preparing an IND may also want to review our guide to IND-enabling studies, which covers the pharmacology, pharmacokinetics, and toxicology work that a Pre-IND meeting is designed to discuss. For programs also evaluating expedited pathways, see our comparison of Fast Track and Breakthrough Therapy designations.
Frequently Asked Questions
1. Can a sponsor request both an INTERACT and a Pre-IND meeting for the same product?
Yes, sequentially. An INTERACT meeting comes earlier, and a Pre-IND meeting follows once the program has advanced. OTP grants one Pre-IND meeting per product and clinical indication, so the Pre-IND cannot be repeated. Follow-up questions arising from INTERACT preliminary responses should be submitted in the Pre-IND package.
2. Is the FDA's feedback at an INTERACT meeting binding?
The advice is initial and non-binding. The FDA guidance covering formal meetings is itself a draft document containing non-binding recommendations. Sponsors should treat the feedback as the agency's current thinking rather than a commitment.
3. How many questions can a sponsor include in a meeting package?
For a 60-minute meeting, a maximum of 10 questions is considered reasonable, and sub-questions count individually. Questions 1a, 1b, 1c, 1d, 2, and 3 count as six questions, not three. Written response only requests are treated as equivalent to a 60-minute meeting and carry the same limit.
4. What happens if the meeting package is submitted late or is incomplete?
For a Pre-IND meeting, OTP will cancel or reschedule the meeting if the package is not submitted on time. For either meeting type, OTP may cancel if the package is grossly inadequate and does not contain enough information for FDA to address the questions. For INTERACT specifically, a request submitted without a package is a documented reason for denial.
5. Do these timelines apply to CDER-regulated products?
The procedural details above reflect OTP's published procedures within CBER. INTERACT and Pre-IND meetings are available for both CDER and CBER products, and the response and scheduling goals derive from PDUFA VII performance goals, but sponsors with a CDER-regulated product should contact CDER for submission instructions and confirm the applicable specifics.
6. Can a sponsor ask FDA which center or office will regulate their product at these meetings?
No. Jurisdiction and regulatory pathway questions fall outside the scope of both INTERACT and Pre-IND meetings, and raising them is a documented reason for denial. FDA directs these questions to separate contacts within the agency.
Accelerate Your Orphan Drug Strategy
Only Orphans Cote helps sponsors secure orphan drug designation faster. Contact us today to schedule a consultation with Dr. Tim Cote and our team.
